FDA event 94233 · Recall Observatory

device · product 1 of 41

Achieva 1.5T, Magnetic Resonance System.

Z-1550-2024

Recall number: Z-1550-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 1,921 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781196, 781296, 781343; UDI-DI n/a; Serial No. 32508, 21935, 32084, 22167, 21313, 21681, 32550, 32717, 32083, 22136, 22319, 32095, 32481, 22001, 21237, 21968, 32474, 32500, 21715, 22245, 21693, 21798, 21572, 22025, 32966, 21045, 22140, 21183, 21962, 32034, 21428, 21192, 21957, 21176, 32171, 22215, 21232, 32085, 22207, 22004, 22066, 21666, 21851, 32390, 21104, 21574, 21272, 21111, 32381, 21598, 21351, 21432, 21965, 21178, 21812, 21805, 21688, 21073, 21120, 21117, 21128, 21085, 21086, 21185, 21162, 21125, 21250, 21153, 21144, 21243, 21235, 21315, 21360, 21265, 21559, 21263, 21244, 21160, 21317, 21342, 21312, 21165, 21274, 21215, 21416, 21136, 21382, 21443, 21454, 21329, 21348, 21226, 21344, 21225, 21297, 21460, 21414, 21281, 21530, 21306, 21444, 21459, 21413, 21430, 21457, 21449, 21052, 21592, 21427, 21431, 21238, 21489, 21488, 21570, 21896, 21625, 21465, 21401, 21578, 21398, 21518, 21295, 21013, 21397, 21134, 21503, 21509, 21624, 21463, 21658, 21588, 21585, 21646, 21647, 21689, 21627, 21711, 21696, 21412, 21699, 21548, 21378, 21654, 21698, 21492, 21707, 21338, 21708, 21690, 21677, 21782, 21787, 21729, 21738, 21731, 21760, 21686, 21914, 22047, 21903, 21750, 21724, 21911, 21794, 21808, 21875, 21876, 21877, 21730, 21815, 21951, 21900, 21100, 21186, 21593, 21655, 21704, 21747, 21751, 21795, 21802, 21984, 21950, 21961, 21919, 21757, 22019, 22233, 21989, 22039, 22032, 22050, 21955, 22037, 22046, 21985, 22002, 22054, 22065, 22028, 22033, 22000, 22062, 21943, 22108, 22038, 21790, 22058, 22068, 21920, 21983, 22006, 22022, 22082, 22078, 22072, 22075, 22076, 22024, 22080, 22023, 22079, 22090, 22016, 21938, 21719, 21753, 22104, 22099, 22262, 22052, 22034, 22029, 22117, 21986, 21496, 22119, 22073, 22126, 22135, 22142, 22056, 21807, 22148, 22150, 22151, 22161, 22178, 22163, 22069, 22125, 22173, 22176, 22179, 22180, 22185, 22187, 22192, 22193, 22195, 22198, 22084, 22162, 22203, 22209, 22153, 21557, 22225, 22186, 22234, 22201, 22239, 22260, 22246, 22250, 22085, 22265, 22261, 22259, 22270, 21626, 22274, 22275, 22277, 22278, 22279, 22293, 22281, 22283, 22291, 22304, 22300, 22302, 22312, 22308, 22309, 22318, 22305, 22311, 22263, 22327, 22326, 22350, 22325, 22330, 22243, 32038, 32006, 22355, 32075, 32089, 21667, 21713, 32108, 21603, 22264, 32100, 32118, 32068, 22183, 22149, 32112, 32011, 32141, 32139, 22204, 32121, 32097, 32156, 32063, 32037, 32160, 32124, 32036, 32149, 32166, 32150, 32093, 32179, 32198, 21609, 32104, 32146, 32136, 32177, 32079, 32067, 32155, 32193, 32255, 32209, 32211, 32222, 32123, 32204, 32205, 32190, 32228, 32231, 32259, 21504, 32216, 32212, 32242, 32248, 32247, 32249, 32263, 32213, 32214, 32265, 32220, 32047, 32274, 32273, 32128, 32275, 32226, 32061, 32246, 32289, 32188, 32192, 32290, 32291, 32294, 32300, 32309, 32243, 21954, 32215, 22071, 21499, 21799, 22021, 21008, 21001, 21083, 21276, 22020, 21897, 21763, 21525, 22287, 32116, 32315, 32317, 32318, 32230, 32306, 32319, 32329, 32321, 32326, 32325, 32332, 32328, 32298, 32241, 32343, 32208, 32345, 32276, 32302, 32354, 32356, 32357, 32288, 32096, 32362, 32365, 32369, 32371, 32304, 32379, 32303, 32372, 32293, 32197, 32380, 32382, 32383, 32386, 32389, 32301, 32367, 32394, 32395, 32396, 32399, 32404, 32400, 32401, 32402, 32715, 32407, 32408, 32387, 32105, 32409, 32415, 32413, 32414, 32416, 32417, 32181, 32420, 32421, 32427, 32425, 32447, 32428, 32429, 32772, 32431, 32342, 32432, 32433, 32434, 32442, 32435, 32437, 32440, 33625, 32552, 32439, 32448, 32451, 32453, 32459, 32460, 32338, 32232, 32466, 32471, 32472, 32475, 21435, 32476, 32464, 32480, 32482, 32418, 32483, 32485, 32486, 32491, 32495, 32183, 32497, 32499, 32377, 32501, 32503, 21190, 32504, 21191, 32519, 32509, 32510, 32514, 32518, 32520, 32521, 32522, 32523, 32524, 32525, 32526, 32527, 32528, 32529, 32490, 32530, 32531, 32532, 32533, 32534, 32535, 32536, 32537, 32538, 32540, 32541, 32051, 32544, 32545, 32546, 32548, 32549, 32339, 32551, 32358, 32462, 22214, 22251, 21188, 32560, 32144, 21810, 21467, 21924, 32101, 32039, 22112, 21425, 32261, 22063, 32187, 32436, 22165, 22170, 21422, 32392, 22269, 32161, 22145, 21956, 32153, 32310, 21594, 21487, 32224, 32199, 21196, 21571, 22226, 21779, 32282, 22232, 22128, 22335, 32558, 32559, 32515, 32561, 32562, 32411, 32563, 32555, 32567, 32487, 32512, 32572, 32502, 32571, 32494, 32576, 32674, 32554, 32307, 32578, 32505, 32582, 32584, 32585, 32569, 32277, 32602, 32624, 32591, 32592, 32574, 32596, 32597, 32604, 32600, 32601, 32603, 32605, 32606, 32609, 32484, 32669, 32611, 32612, 32613, 32614, 32615, 32617, 32618, 32989, 32493, 32608, 32853, 32619, 32620, 21500, 32625, 32627, 32626, 32628, 32632, 32629, 32565, 32630, 32750, 32631, 32633, 32637, 32635, 32638, 32639, 32640, 32642, 22242, 32645, 32646, 32647, 32648, 32649, 32650, 32570, 32651, 32652, 32654, 32658, 32656, 32657, 32660, 32598, 32662, 32664, 32667, 32671, 32677, 32679, 32681, 32683, 32684, 32686, 32688, 32690, 21988, 32691, 32692, 32693, 32694, 32695, 32697, 32700, 32701, 32702, 32706, 32711, 32703, 32704, 32705, 32708, 32746, 32713, 32714, 32659, 32720, 32721, 32723, 32731, 32740, 32699, 32736, 32728, 32727, 32733, 32737, 32729, 32641, 32748, 32749, 32751, 32758, 32786, 32759, 32768, 32764, 32763, 32765, 32820, 32783, 32808, 32767, 32766, 32824, 32769, 32770, 32159, 32634, 32773, 32587, 32774, 32776, 32777, 32779, 32780, 32781, 32782, 32734, 32785, 32787, 32788, 32789, 32790, 32793, 32795, 32794, 32655, 32797, 32799, 32800, 32801, 32802, 32806, 32809, 32810, 32811, 32813, 32817, 32812, 32814, 32829, 32815, 32775, 32819, 32818, 32821, 32747, 32823, 32756, 32826, 32831, 32832, 32834, 32835, 32836, 32863, 32837, 32852, 32843, 32860, 32842, 32846, 32847, 32848, 32850, 32855, 32856, 32861, 32865, 32866, 32867, 32868, 32869, 32870, 21096, 32871, 32872, 32873, 32874, 32877, 32878, 32879, 32887, 32880, 32888, 21197, 21569, 32881, 32882, 32229, 32885, 32886, 32889, 32890, 32892, 32753, 32893, 32894, 32897, 32964, 32901, 32862, 32898, 32899, 32974, 32900, 22210, 32902, 32903, 32905, 32908, 32909, 32517, 32911, 32912, 32913, 32914, 32916, 32917, 32922, 32921, 32925, 32931, 32926, 32927, 32928, 32933, 32934, 32936, 32940, 32876, 32595, 32944, 32959, 32945, 32948, 32950, 32951, 32952, 32955, 32954, 32957, 33067, 32962, 32965, 32967, 32370, 32968, 32969, 32970, 32971, 32975, 32976, 32977, 32979, 32980, 32983, 32981, 32982, 32986, 32987, 21508, 32938, 32991, 32932, 32988, 32943, 32992, 32997, 32995, 32998, 33000, 33001, 33002, 33004, 33006, 33007, 33010, 33008, 33009, 33012, 33011, 32825, 33024, 33015, 21993, 33016, 33017, 33018, 33020, 33021, 33027, 33029, 32376, 32003, 33031, 33032, 33030, 33036, 21224, 33040, 33041, 33042, 33046, 33049, 33013, 33057, 33055, 33056, 33064, 33063, 33061, 33060, 32996, 33065, 33066, 21168, 33068, 33070, 33071, 33087, 33073, 33076, 33078, 33081, 33088, 33123, 33142, 21589, 33096, 32738, 33274, 33101, 33102, 32741, 32985, 33107, 32956, 33110, 33112, 33120, 33115, 33047, 33026, 33116, 33117, 33118, 33119, 33099, 33053, 32930, 33108, 33109, 32816, 33128, 33127, 33105, 33129, 33132, 33043, 33133, 33134, 33135, 33136, 33097, 32716, 33158, 33146, 33148, 33111, 33083, 33161, 33091, 33163, 33124, 33164, 33140, 33166, 33167, 33168, 33170, 33094, 33157, 33144, 33172, 33173, 33174, 33171, 33143, 33153, 33152, 33181, 33150, 33147, 33160, 33182, 33155, 32994, 33090, 33156, 33141, 33187, 33188, 33189, 33190, 33191, 33192, 33194, 33195, 33196, 33197, 33200, 33201, 33202, 33203, 33204, 33175, 33214, 33216, 33222, 33223, 33186, 33224, 33165, 33225, 33221, 33226, 33227, 33183, 33228, 33231, 33229, 33079, 32993, 33232, 33233, 33205, 33178, 33236, 33237, 33238, 33239, 33241, 33125, 33242, 33245, 33248, 33249, 33149, 33218, 33254, 33255, 33256, 33139, 33151, 33259, 33260, 33261, 33263, 33265, 33266, 33267, 33268, 33272, 33185, 21545, 33275, 33278, 33291, 33292, 33093, 33282, 33206, 33283, 33207, 33284, 33289, 33286, 33287, 33244, 33209, 33253, 33293, 33294, 33296, 33297, 33299, 33300, 33302, 33301, 33303, 33304, 33219, 33180, 33305, 33306, 33177, 33240, 33311, 33258, 33313, 33154, 33314, 33251, 32875, 33234, 33235, 33318, 33176, 33089, 33084, 33329, 33330, 33335, 33351, 33338, 33269, 33336, 33339, 33341, 33342, 33346, 33343, 33344, 33345, 33279, 33348, 33347, 33349, 33252, 33369, 33360, 33361, 33363, 33312, 33362, 33364, 33365, 33367, 33368, 32973, 33370, 33372, 33392, 33471, 33375, 33374, 33376, 33328, 33377, 33379, 33380, 33382, 33383, 33386, 33387, 33388, 33452, 33389, 33058, 33098, 33394, 33393, 33080, 33398, 33397, 33396, 33399, 33402, 33406, 33408, 33409, 33410, 33412, 33413, 33414, 33416, 33454, 33456, 33417, 33418, 33419, 33421, 33423, 33422, 33426, 33432, 33504, 33428, 33430, 33425, 33433, 33435, 33434, 33462, 33627, 33438, 33925, 33439, 33441, 33443, 33444, 33445, 33446, 33447, 33449, 33453, 33455, 33458, 33463, 33464, 33465, 33470, 33407, 33468, 33474, 33476, 33475, 33130, 33378, 33478, 33479, 33480, 33483, 33491, 33482, 33484, 32978, 33485, 33488, 33490, 33492, 33493, 33494, 33086, 33497, 33499, 33500, 33333, 33050, 32424, 33501, 33502, 33503, 33505, 33506, 33507, 33508, 33509, 33510, 33512, 33515, 33514, 33516, 33250, 33095, 33517, 33518, 33519, 33521, 33523, 33524, 33525, 33526, 33527, 33298, 33528, 33530, 33531, 33532, 33533, 33537, 21868, 33539, 33541, 33540, 33542, 33544, 33543, 33545, 33547, 33548, 33549, 33550, 33551, 33552, 22130, 33553, 33554, 33555, 33535, 33557, 33556, 33560, 33558, 33562, 33561, 33563, 33564, 33566, 33568, 33569, 33570, 33571, 33459, 33575, 33576, 33577, 33322, 33578, 33579, 33581, 33582, 33584, 33585, 33586, 33588, 33589, 33590, 33587, 33591, 33595, 33594, 33596, 33597, 33605, 33603, 33606, 33608, 33607, 33609, 33610, 33611, 33340, 33632, 33626, 33633, 33628, 33285, 21982, 33634, 33636, 33638, 33637, 33668, 33644, 33642, 33643, 33645, 33646, 33647, 33648, 33649, 33650, 33651, 33670, 33652, 33655, 33654, 33656, 33658, 33669, 33660, 33661, 21639, 33662, 33664, 33665, 33666, 33684, 33673, 33674, 33675, 33676, 33680, 72029, 33681, 32644, 33683, 72010, 33688, 33687, 33689, 33691, 33690, 33692, 33696, 33695, 33131, 72003, 21211, 21550, 72007, 33052, 33700, 33701, 33702, 72005, 33704, 21264, 33705, 33706, 33851, 33710, 72016, 72015, 72001, 33713, 33714, 33715, 33717, 33722, 33723, 33724, 33726, 33727, 32792, 33728, 33730, 33731, 33736, 33699, 33534, 33740, 33741, 33742, 33746, 33747, 33748, 33749, 33751, 33750, 33752, 33754, 33756, 33755, 72012, 72018, 72020, 72019, 72160, 72022, 72023, 72025, 72247, 72154, 72038, 72157, 72032, 72036, 72034, 33764, 33766, 33767, 33768, 72040, 33774, 72153, 33771, 33772, 33773, 72159, 72156, 72136, 72047, 72048, 72049, 72052, 33777, 33778, 33779, 33781, 72053, 33782, 33854, 33085, 33784, 33787, 33788, 33257, 72249, 33718, 33806, 33849, 33815, 33850, 72145, 33794, 33797, 33072, 22159, 72134, 33823, 33805, 33825, 33828, 33830, 33852, 33836, 33837, 72111, 72113, 72112, 33838, 33839, 33848, 33842, 33846, 33841, 72109, 33807, 72114, 72118, 72120, 72119, 72121, 72122, 72124, 72123, 72126, 72128, 72129, 33853, 72137, 72138, 72140, 72139, 72141, 72143, 72142, 72144, 72147, 72148, 72150, 72151, 72152, 33855, 33856, 33858, 33859, 72168, 72170, 33865, 33864, 72174, 72171, 72251, 33866, 72173, 33867, 36001, 33883, 33872, 33873, 33874, 33875, 33942, 33880, 33881, 33884, 33885, 72175, 72177, 72176, 32272, 33887, 33888, 72183, 72013, 21796, 21996, 22041, 33138, 32143, 33895, 33896, 33897, 33898, 33894, 33900, 33902, 33972, 33903, 33906, 33909, 33910, 72185, 33928, 33911, 72194, 33916, 33947, 33955, 33919, 33920, 72186, 72188, 72189, 33941, 33921, 33922, 72190, 21925, 72192, 72193, 72195, 72196, 72199, 72200, 33924, 72201, 72202, 72203, 72204, 32148, 33932, 33933, 33934, 33939, 72207, 72217, 72255, 72253, 72260, 72257, 72256, 72259, 72254, 72258, 33938, 33940, 72221, 33943, 32346, 21269, 33935, 33936, 72223, 72180, 33945, 72227, 33958, 33948, 33949, 72264, 33983, 33950, 33952, 32233, 36005, 32351, 72228, 33954, 33961, 72230, 72231, 33957, 33963, 33959, 72232, 33960, 33962, 72237, 33964, 72236, 72233, 33956, 33965, 33981, 33966, 72235, 72234, 33967, 72238, 33968, 72240, 33973, 33977, 33974, 72309, 33975, 33976, 33978, 72244, 33979, 32201, 33984, 32210, 72265, 72266, 33982, 72267, 72269, 33985, 33986, 36002, 22217, 33988, 72270, 72271, 72273, 33989, 36000, 33991, 33994, 33992, 36009, 33996, 33995, 21556, 36004, 36006, 36007, 36008, 72279, 72224, 36013, 36015, 36016, 36017, 36018, 36010, 21630, 72280, 72281, 36019, 72287, 36020, 32689, 72288, 36023, 32712, 72290, 72292, 36021, 36022, 22095, 36024, 36027, 36028, 36025, 72294, 36026, 36030, 36029, 36032, 36031, 36033, 72304, 72301, 72302, 36034, 36035, 36036, 36037, 32581, 72303, 36038, 36041, 36042, 36040, 36056, 36043, 72278, 36045, 36046, 36047, 36048, 72306, 36049, 36050, 36057, 36051, 36062, 36054, 36065, 32907, 36058, 72308, 22315, 36061, 36069, 72310, 36070, 36063, 36071, 72312, 72311, 72313, 36077, 36078, 72316, 36079, 22223, 33122, 36081, 72318, 72317, 36082, 22110, 36083, 36093, 36084, 36091, 36085, 36086, 36092, 36089, 36087, 36088, 72321, 72320, 36095, 72319, 36103, 36108, 36109, 36110, 72226, 36107, 36106, 13051, 36105, 72324, 72325, 21776, 21284, 72326, 72327, 21754, 32001, 32616, 21674, 72116, 72117, 22129, 32668, 21246, 21252, 21474, 21675, 21651, 21495, 32739, 21455, 21076, 21405, 32463, 36099, 22155, 21240, 21320, 21879, 21479, 32080, 21475, 21066, 32151, 21251, 33678, 33679, 33538, 33677, 33686, 32254, 32757, 32430, 21678, 21558, 21113, 32314, 21321, 32002, 21334, 22286, 21009, 21077, 21112, 21254, 32122, 32320, 21494, 32388.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 2 of 41

Achieva 1.5T Conversion, Magnetic Resonance System.

Z-1551-2024

Recall number: Z-1551-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 115 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781283, 781346; UDI-DI n/a; Serial No. 39025, 8020, 39027, 39060, 39016, 39079, 39022, 39001, 8467, 39013, 39006, 39004, 39007, 39008, 39011, 39010, 39012, 39026, 39023, 39028, 39032, 39029, 39034, 39030, 39052, 39053, 39064, 39039, 39054, 39056, 39036, 39041, 39038, 39065, 39066, 39067, 39040, 39057, 39042, 39072, 39071, 39073, 39074, 39058, 39059, 39078, 39081, 39075, 39083, 39082, 39085, 39077, 39086, 39084, 39080, 39062, 39089, 39092, 39096, 39098, 39100, 39094, 39088, 39091, 39093, 39104, 39105, 75000, 75007, 39099, 39107, 75001, 39102, 75002, 39097, 75003, 75004, 75015, 39095, 75031, 8276, 75011, 75005, 10512, 75010, 75049, 10189, 10048, 8069, 10006, 8312, 8520, 18588, 18052, 5547, 10015, 8740, 8415, 10539, 75009, 10194, 8714, 5243, 10172, 39090, 18737, 8727, 8367, 8289, 39061, 75068, 8782, 75008, 8361, 8371.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 3 of 41

Achieva 1.5T Initial, Magnetic Resonance System.

Z-1552-2024

Recall number: Z-1552-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 69 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781178; UDI-DI n/a; Serial No. 20126, 20129, 20062, 20297, 20307, 20150, 20248, 20096, 20252, 20257, 20282, 20149, 20072, 20277, 20281, 20185, 20081, 20018, 20042, 20139, 20113, 20095, 20133, 20124, 20194, 20217, 20080, 20241, 20222, 20162, 20010, 20320, 20259, 20167, 20114, 20130, 20335, 20326, 20323, 20274, 20157, 20040, 20117, 20037, 20098, 20079, 20258, 20087, 20043, 20094, 20191, 20088, 20331, 20172, 20028, 20210, 20179, 20291, 20050, 20173, 20303, 20023, 20224, 20047, 20066, 20085, 20056, 20083, 20230.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 4 of 41

Achieva 3.0T, Magnetic Resonance System.

Z-1553-2024

Recall number: Z-1553-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 511 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781177, 781277, 781278, 781344, 781345; UDI-DI n/a; Serial No. 17108, 24070, 24114, 34066, 24053, 17235, 17256, 17244, 17114, 34028, 38018, 17049, 17217, 38033, 17319, 17347, 17094, 34065, 17430, 34085, 17392, 17385, 17494, 17384, 17461, 17119, 17043, 17561, 17453, 17093, 17414, 17393, 17365, 17216, 24040, 17035, 17017, 17039, 17025, 17051, 17008, 17091, 17126, 17099, 17166, 17171, 17238, 17189, 17234, 17233, 17279, 17185, 17257, 17343, 17294, 17334, 17295, 17243, 17285, 17057, 17118, 17178, 17374, 17139, 17371, 17379, 17427, 17402, 17359, 17394, 17469, 24014, 17412, 17413, 17452, 17358, 17431, 17446, 17451, 17404, 17535, 17433, 17443, 17424, 17144, 17147, 17448, 17324, 17161, 24009, 17150, 17591, 17500, 24010, 17361, 24005, 17596, 17498, 17362, 17617, 17418, 24049, 24082, 17432, 17011, 24056, 24062, 24068, 24081, 24079, 17607, 24052, 24091, 24096, 24099, 34022, 24116, 17450, 24120, 24130, 24125, 17426, 24131, 34002, 17349, 34023, 24135, 24138, 34043, 34094, 17167, 34086, 34047, 38002, 34033, 34011, 34052, 34095, 38003, 34082, 34109, 34113, 34120, 17124, 34104, 34123, 38012, 38017, 24154, 34077, 38022, 34122, 34139, 17072, 17131, 17377, 24060, 34138, 34135, 34125, 34144, 34130, 38009, 34208, 34056, 38031, 34106, 38044, 38079, 34140, 34118, 34159, 34160, 38046, 34165, 38042, 38049, 38060, 38054, 38057, 17435, 34206, 38059, 38064, 34020, 38072, 38067, 38069, 38043, 34038, 38073, 38078, 34220, 34226, 34225, 38021, 34074, 34228, 38056, 38082, 34230, 38074, 38085, 38086, 38061, 38087, 38090, 34232, 38093, 38095, 34207, 38098, 38099, 38101, 38055, 34115, 38104, 34213, 34234, 38112, 34200, 38114, 38113, 34231, 38115, 34235, 34239, 34240, 34241, 34242, 38124, 38128, 38108, 38130, 38220, 38144, 38137, 38139, 38140, 38141, 38143, 38145, 38151, 38152, 38154, 38158, 38162, 34253, 34247, 38167, 38160, 38150, 38133, 38171, 38172, 38169, 38174, 38170, 38181, 34254, 38185, 38186, 38197, 38187, 38188, 38189, 38190, 38191, 34258, 34260, 34263, 34264, 38193, 38194, 38200, 38196, 34255, 34268, 34269, 38205, 38206, 38207, 38209, 38210, 34270, 38216, 38223, 34256, 17168, 24019, 38157, 38227, 34272, 38228, 34273, 38232, 38229, 38230, 38231, 38234, 34271, 34274, 38241, 34275, 38237, 24097, 38238, 34276, 38240, 38244, 38245, 38246, 38247, 38248, 38249, 38269, 38251, 38253, 38254, 38255, 38256, 38258, 38260, 17558, 34281, 34282, 38261, 38262, 17134, 38266, 38212, 38265, 38173, 38268, 38270, 38271, 38272, 17304, 38233, 38273, 38257, 38274, 38276, 38279, 17380, 38264, 34286, 38280, 38283, 38282, 38285, 17316, 38288, 38291, 34285, 38293, 34287, 38295, 38297, 38298, 38299, 24059, 34288, 38267, 34289, 38278, 38302, 38292, 38303, 17296, 38304, 34290, 38307, 34291, 38252, 38284, 38312, 38313, 38314, 38215, 38315, 38236, 34293, 38016, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 34294, 34295, 38327, 38328, 38329, 17034, 38330, 38331, 38332, 38287, 38336, 38337, 34297, 38338, 34298, 38339, 34299, 38340, 38335, 34300, 38343, 38344, 38345, 38346, 38347, 38349, 34301, 38351, 34304, 38355, 38359, 38360, 38361, 38363, 17038, 34305, 34306, 73002, 73003, 73004, 74001, 74002, 73009, 73008, 73005, 74027, 24038, 34073, 73006, 74004, 38354, 34308, 34312, 74005, 74020, 74009, 74007, 34309, 74010, 74021, 17042, 74026, 74029, 74030, 17497, 38127, 74032, 74033, 74046, 74034, 74035, 38004, 34071, 34029, 74044, 74041, 73010, 74039, 74047, 74048, 17075, 17460, 74052, 34030, 17270, 34034, 17070, 34143, 38103, 17251, 24089, 17456, 17001, 34201, 17445, 24050, 38007, 17149, 17085, 24045, 34001, 17179, 38341, 17170, 17523, 17551, 24037, 17187, 17056, 17599, 17102, 17313, 24078, 17079, 17130, 17103, 17142, 17146, 17183, 17437.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 5 of 41

Achieva 3.0T for PET, Magnetic Resonance System.

Z-1554-2024

Recall number: Z-1554-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781477; UDI-DI n/a; Serial No. 43006.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 6 of 41

Achieva 3.0TX for PET, Magnetic Resonance System.

Z-1555-2024

Recall number: Z-1555-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781479; UDI-DI n/a; Serial No. 43102.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 7 of 41

Achieva XR, Magnetic Resonance System.

Z-1556-2024

Recall number: Z-1556-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 49 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781153, 781253; UDI-DI n/a; Serial No. 35075, 23028, 23017, 23021, 35006, 35015, 35016, 35021, 23009, 23003, 23031, 23005, 23035, 23040, 35007, 35022, 35025, 35028, 35024, 35035, 35039, 35049, 35055, 35013, 35064, 35063, 35071, 35068, 35069, 35070, 35067, 35081, 35011, 35083, 35084, 35082, 23020, 23038, 35076, 35020, 35085, 35050, 35057, 23014, 35004, 35061, 35074, 23004, 23029.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 8 of 41

Enterprise 1.5T, Magnetic Resonance System.

Z-1557-2024

Recall number: Z-1557-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781145; UDI-DI n/a; Serial No. 10709, 10682, 10678, 10729, 10217, 10031, 10092, 10111, 10715, 10074, 10121, 10122, 10119, 10732, 10775, 10795, 10041, 10711, 10144, 10792, 10787, 10689, 10218, 10704, 10693, 10685, 10696, 10687, 10726, 10797, 10799, 10789, 10790.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 9 of 41

Evolution Upgrade 3.0T, Magnetic Resonance System.

Z-1558-2024

Recall number: Z-1558-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 782143; UDI-DI n/a; Serial No. 85699.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 10 of 41

GYROSCAN ACS-NT, Magnetic Resonance System.

Z-1559-2024

Recall number: Z-1559-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 78107; UDI-DI n/a; Serial No. 5533, 5414, 5245, 5542, 5300, 5227, 5472, 5193, 5413, 5216, 5029, 5460, 5437, 5213, 5295, 5302, 5387, 5468, 5098, 5339, 5156, 5349, 5334, 5513, 5461, 5545, 5177, 5564, 5102, 5134, 5288, 5168, 5428, 5411, 5519, 5323, 5561, 5230, 5142, 5082, 5014, 5110, 5052, 5379, 5137, 5389, 5403, 5232, 5556, 5065.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 11 of 41

GYROSCAN T10-NT, Magnetic Resonance System.

Z-1560-2024

Recall number: Z-1560-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 78108; UDI-DI n/a; Serial No. 4221, 4332, 4209, 4235, 4083, 4368, 4090, 4171, 4182, 4217, 4276, 4360, 4115, 4157, 4181, 4215, 4234, 4238, 4239, 4242, 4245, 4277, 4351, 4399, 4029, 4072, 4097, 4110, 4228, 4375, 4408, 4284, 4376, 4396, 4168, 4224, 4289, 4377, 4014, 4081.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 12 of 41

GYROSCAN T5, Magnetic Resonance System.

Z-1561-2024

Recall number: Z-1561-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 78104; UDI-DI n/a; Serial No. 605, 889, 915, 938, 663, 600, 891.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 13 of 41

GYROSCAN T5-NT, Magnetic Resonance System.

Z-1562-2024

Recall number: Z-1562-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 78106; UDI-DI n/a; Serial No. 1194, 1249, 1009, 1161, 1091, 1130, 1183, 1196, 1260, 1151, 1022, 1126, 1176, 1211, 1238, 1256, 1070, 1233, 1270, 1198, 1234, 1148, 1128, 1245.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 14 of 41

Ingenia 1.5T, Magnetic Resonance System.

Z-1563-2024

Recall number: Z-1563-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 2,242 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781396, 781315, 782115, 781341, 782101; UDI-DI 884838055322, 884838099715, 884838099043, 884838098275; Serial No. Serial Number, 70051, 84508, 84243, 41044, 84400, 84537, 41569, 41104, 41203, 41195, 70743, 87103, 70892, 41525, 84283, 70044, 41034, 84475, 84628, 87057, 41028, 84538, 84505, 41305, 70619, 84186, 70752, 61049, 41067, 41406, 41265, 41409, 70135, 70676, 70694, 70903, 84816, 41438, 41057, 41517, 41356, 84147, 41263, 41463, 41277, 84192, 61094, 70925, 41018, 70049, 61282, 84026, 84439, 84286, 41149, 70646, 70793, 70928, 70661, 41481, 87231, 84514, 84929, 61331, 84200, 70063, 41173, 41036, 87017, 70783, 41166, 84646, 84170, 70715, 41116, 70874, 70672, 41475, 41134, 41420, 41462, 41358, 84627, 61207, 70094, 84970, 41511, 70808, 41484, 41342, 61105, 84240, 84942, 41005, 70447, 41222, 87132, 84063, 41532, 41311, 84446, 41426, 84614, 84196, 41291, 41555, 87133, 41434, 41312, 84506, 70095, 70762, 41046, 41237, 84526, 84791, 84174, 41090, 41171, 41427, 84866, 70076, 84088, 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84485, 61092, 61091, 61093, 61102, 61103, 61095, 87282, 41425, 87283, 61106, 61107, 61108, 61109, 61114, 87284, 87285, 87291, 87289, 61124, 61119, 61125, 61117, 61116, 61115, 87601, 87294, 87296, 84911, 84824, 84823, 61126, 61129, 61130, 87299, 87607, 87610, 87608, 61131, 87300, 87605, 87609, 84954, 61138, 61175, 61185, 61184, 61188, 41097, 61195, 61192, 61193, 61191, 61187, 61179, 61189, 61181, 61176, 87602, 61186, 61182, 61178, 61198, 61199, 61200, 61183, 61203, 61140, 61202, 61180, 87302, 61142, 61177, 61275, 61204, 61206, 61205, 87303, 61208, 61210, 87305, 61209, 61212, 61211, 61213, 61227, 87276, 61218, 61143, 87307, 61240, 61219, 61220, 61221, 61223, 61222, 61224, 61225, 61228, 61226, 61264, 61231, 61234, 61260, 61259, 87613, 61235, 61144, 87311, 61236, 87312, 61237, 61238, 87614, 61248, 61249, 87245, 61256, 61214, 61246, 61243, 87314, 61286, 61245, 61250, 87315, 61252, 61253, 41083, 61274, 61258, 61257, 61284, 61261, 61262, 61312, 61311, 61310, 41206, 41313, 61263, 87617, 41512, 61266, 61265, 61268, 61269, 61270, 61271, 70835, 61273, 87317, 87318, 61276, 61279, 61281, 87319, 61288, 61294, 61293, 41003, 61287, 61289, 41242, 61292, 61295, 87320, 61112, 61298, 61299, 61300, 61201, 61306, 61383, 61303, 61304, 41158, 61232, 61313, 61314, 61315, 41260, 61316, 70233, 61321, 61320, 61317, 61319, 41290, 70200, 61327, 61326, 61328, 61329, 61330, 61332, 61334, 61336, 61337, 61338, 61216, 61341, 61348, 61351, 61356, 61352, 61360, 61357, 87326, 61358, 61242, 87633, 61359, 61285, 87636, 41073, 61377, 61406, 61378, 61280, 61302, 61380, 61272, 87632, 87639, 61381, 61382, 61386, 61390, 61350, 61283, 87644, 87638, 61385, 87649, 87631, 87641, 87627, 87642, 61394, 87643, 61395, 61397, 61401, 61403, 61404, 84462, 84973, 61407, 61291, 84340, 84993, 70758, 84344, 61416, 61417, 61420, 61421, 61419, 61415.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 15 of 41

Ingenia 1.5T CX, Magnetic Resonance System.

Z-1564-2024

Recall number: Z-1564-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781261, 781262; UDI-DI 884838068438; Serial No. Serial Number, 77000, 77002, 77001, 77004, 77007, 77008, 77010, 77016, 77019, 77030, 77031, 77043, 77032, 77033, 77041, 77034, 77035, 77036, 77037, 77038, 77039, 77040, 77042, 77044, 77046, 77091, 77047, 77048, 77049, 77050, 77053, 77054, 77059, 77051, 77055, 77056, 77052, 77057, 77058, 77060, 77062, 77063, 77061, 77065, 77069, 77068, 77067, 77066, 77070, 77072, 77159, 77127, 77171, 77071, 77074, 77075, 77081, 77094, 77078, 77087, 77092, 77083, 77084, 77118, 77086, 77085, 77088, 77090, 77093, 77097, 77100, 77101, 77103, 77105, 77106, 77107, 77109, 77111, 77110, 77112, 77113, 77114, 77115, 77117, 77119, 77120, 77121, 77122, 77128, 77130, 77123, 77126, 77125, 77124, 77129, 77141, 77138, 77135, 77134, 77136, 77139, 77137, 77131, 77045, 77143, 77150, 77144, 77147, 77151, 77154, 77155, 77157, 77156, 77158, 77160, 77161, 77162, 77166, 77167, 77169, 77168, 77172, 77177, 77178, 77179, 77180, 77181, 77182, 77183, 77185, 77187, 77188, 77190, 77191, 77193, 77194, 77195, 77196, 77198, 77201, 77199, 77203, 77202.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 16 of 41

Ingenia 1.5T S, Magnetic Resonance System.

Z-1565-2024

Recall number: Z-1565-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 135 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781347; UDI-DI 884838068421; Serial No. 81034, 81033, 81015, 81113, 81080, 81103, 81137, 81001, 81003, 81004, 81014, 81007, 81006, 81009, 81010, 81011, 81062, 81020, 81016, 81017, 81018, 81019, 81023, 81025, 81024, 81027, 81028, 81030, 81031, 81032, 81035, 81056, 81037, 81057, 81055, 81060, 81038, 81040, 81041, 81043, 81044, 81047, 81045, 81039, 81050, 81051, 81052, 81061, 81063, 81064, 81065, 81074, 81067, 81079, 81069, 81070, 81116, 81071, 81075, 81076, 81077, 81085, 81078, 81084, 81090, 81086, 81088, 81087, 81092, 81091, 81093, 81095, 81094, 81096, 81097, 81098, 81100, 81111, 81105, 81106, 81185, 81108, 81127, 81112, 81049, 81114, 81115, 81117, 81122, 81118, 81126, 81124, 81129, 81131, 81132, 81133, 81128, 81139, 81138, 81140, 81148, 81146, 81147, 81149, 81151, 81152, 81153, 81155, 81046, 81048, 81156, 81158, 81157, 81072, 81159, 81154, 81162, 81164, 81165, 81167, 81170, 81171, 81172, 81123, 81173, 81174, 81029, 81176, 81178, 81179, 81180, 81175, 81184, 81042, 81058.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 17 of 41

Ingenia 3.0T, Magnetic Resonance System.

Z-1566-2024

Recall number: Z-1566-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 1,509 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781377, 781342, 782103; UDI-DI 884838009813, 884838055339, 884838098299; Serial No. 42003, 71336, 42370, 71022, 42368, 42117, 42066, 42052, 42040, 42242, 71399, 42241, 42099, 42126, 42127, 71045, 42258, 42033, 85154, 42352, 85655, 42248, 71739, 71829, 71495, 42307, 71038, 42286, 71810, 42247, 71185, 42152, 71449, 42104, 42006, 42158, 42159, 42160, 71331, 71382, 71312, 71907, 42116, 71683, 71062, 42416, 42109, 42293, 42031, 42098, 42193, 42102, 71193, 85665, 42366, 42180, 42266, 42032, 85221, 42274, 42229, 42414, 71456, 42001, 42053, 42083, 42177, 71277, 42059, 71071, 42365, 71286, 71836, 42068, 71203, 71190, 71379, 42403, 71732, 71194, 85644, 85643, 42322, 42342, 42035, 42057, 71982, 71646, 42334, 71914, 71378, 71960, 71317, 71959, 71191, 42240, 42356, 42197, 85681, 42005, 71319, 42002, 42007, 42008, 42009, 42010, 42011, 42012, 42013, 42015, 42017, 42018, 42021, 42014, 42023, 42024, 42026, 42123, 42027, 42028, 42030, 42049, 42037, 42041, 42042, 42043, 71735, 42047, 42048, 42055, 42056, 42062, 42069, 42058, 42073, 42061, 42065, 42070, 42072, 42078, 42074, 42077, 42079, 42086, 42081, 42082, 42087, 42088, 42089, 42111, 42090, 42092, 42187, 42093, 42094, 42095, 42103, 42105, 42107, 42110, 42125, 42114, 42112, 42115, 42147, 42122, 42121, 42120, 42124, 42128, 42130, 42133, 42131, 42132, 42135, 42134, 42136, 42137, 42138, 42141, 42143, 42144, 42145, 42151, 42153, 42190, 42161, 42162, 85094, 42164, 42165, 42170, 42171, 42175, 42176, 42178, 42179, 42198, 42183, 42184, 42186, 42194, 42191, 42192, 42195, 42201, 42203, 42204, 42205, 42206, 42209, 42210, 42211, 42213, 42216, 42215, 42219, 42225, 42218, 71529, 42067, 42223, 42220, 42222, 42228, 42230, 42232, 42233, 42234, 42235, 42236, 42237, 85275, 42243, 42245, 42231, 42221, 42244, 42249, 42250, 42251, 42199, 42252, 42076, 42253, 42224, 42256, 42257, 42260, 42261, 42262, 42263, 42264, 42271, 42273, 42275, 42276, 42277, 42278, 42279, 42287, 42282, 42285, 42330, 42288, 42289, 42294, 42283, 42299, 42300, 42301, 42360, 42303, 71329, 42291, 42305, 42308, 42309, 42314, 42315, 42332, 42320, 42364, 42321, 42323, 42272, 42167, 71164, 42331, 42369, 42333, 42267, 42337, 42338, 42339, 42340, 42254, 42343, 42345, 42346, 42347, 42348, 42349, 42354, 42350, 42351, 42393, 42353, 71483, 42214, 42355, 42358, 42318, 42359, 42361, 42362, 42363, 42367, 71893, 42378, 42280, 42381, 42383, 42384, 42385, 42386, 42319, 42387, 42388, 42380, 42390, 42392, 42413, 42396, 42398, 42399, 42407, 42401, 42402, 42404, 42408, 42409, 42412, 42326, 42419, 42420, 42421, 42422, 42424, 42426, 42429, 42428, 42432, 42499, 42423, 42503, 42436, 42435, 42437, 42438, 71291, 42439, 71004, 71008, 71002, 42440, 71007, 71376, 42441, 71003, 42442, 71011, 71012, 71013, 71014, 42189, 42444, 42445, 71001, 42446, 71192, 71026, 71017, 71018, 71020, 71173, 71006, 42448, 71828, 42449, 42450, 71035, 71037, 71070, 71195, 71039, 42451, 42452, 71040, 71198, 42454, 42453, 71047, 71060, 71081, 71051, 42455, 42019, 71061, 71276, 42458, 42457, 42500, 42459, 71346, 71188, 71056, 71183, 71058, 42463, 71204, 71068, 71077, 71072, 71189, 42425, 71078, 71397, 71208, 71097, 71084, 71086, 71174, 42464, 71087, 71197, 71224, 71088, 71089, 71093, 42466, 71095, 71280, 71106, 71278, 71101, 71283, 71175, 42502, 42490, 71107, 71150, 71308, 71156, 71152, 71154, 71155, 71268, 42491, 71157, 71323, 71159, 42492, 71161, 71162, 42493, 71165, 42494, 42495, 42496, 71163, 71166, 71375, 42469, 71168, 71287, 71285, 71170, 71023, 71172, 71176, 71177, 71178, 71179, 71181, 71184, 71211, 71210, 42415, 71288, 42504, 42505, 42507, 71214, 42508, 71215, 71424, 71271, 71279, 71220, 71318, 42510, 42512, 42520, 85057, 71225, 71227, 71228, 71231, 71282, 71252, 71313, 71315, 71260, 71324, 71267, 71262, 42506, 71263, 71314, 71296, 71266, 71300, 42522, 71416, 71272, 71270, 71269, 71299, 71341, 71445, 71446, 71311, 71301, 71302, 71359, 71303, 71326, 42525, 71335, 71304, 71305, 71307, 71451, 71309, 71337, 42530, 42528, 71031, 71320, 71321, 71328, 71332, 71333, 71334, 71338, 71339, 71340, 71290, 71343, 71342, 71361, 71345, 71344, 71348, 71354, 71347, 42543, 71349, 42545, 42547, 42546, 42548, 71357, 71350, 42549, 71351, 71356, 71352, 71353, 71360, 71556, 42554, 42552, 42553, 42555, 71366, 42556, 71368, 71367, 42557, 71371, 42558, 71372, 71373, 71374, 42560, 71377, 71380, 71381, 42036, 71398, 71393, 71394, 71385, 71386, 71489, 71387, 71389, 42561, 42559, 71390, 71396, 71400, 71438, 71392, 71395, 71401, 71402, 71459, 71403, 71405, 71406, 71411, 71408, 42565, 71410, 71409, 71412, 71413, 71414, 71418, 71419, 42563, 71420, 71422, 71428, 71423, 71425, 71426, 71427, 71429, 71441, 71751, 71433, 71434, 71436, 71437, 85278, 42570, 71440, 71439, 71442, 71365, 71448, 71450, 71453, 71452, 71462, 71460, 71457, 71464, 71461, 71463, 71465, 71467, 71470, 71468, 71471, 71472, 71475, 71473, 71486, 71487, 71476, 71477, 71478, 71485, 71490, 71576, 42531, 71479, 71480, 71481, 71482, 71484, 71492, 71493, 71298, 71613, 71874, 71496, 71497, 71504, 71521, 71501, 71498, 71499, 71500, 71522, 71505, 71506, 71509, 71508, 71510, 71511, 71519, 71512, 71514, 71520, 71516, 71517, 71518, 42100, 71526, 71524, 71527, 71534, 71541, 71548, 71544, 71545, 71557, 71550, 71551, 71553, 71554, 71555, 71558, 71560, 71559, 71491, 71567, 71563, 71562, 71565, 71564, 71566, 71443, 71571, 71574, 71575, 71577, 42038, 71580, 71582, 71581, 71587, 71597, 71589, 71590, 71592, 71594, 71630, 71010, 71600, 71596, 71474, 71213, 71601, 71588, 71583, 71750, 71602, 71614, 71603, 71604, 71605, 71608, 71607, 71610, 71609, 71620, 71619, 71742, 71612, 71611, 71615, 71616, 71618, 71629, 71621, 71624, 71622, 71623, 71660, 71625, 71626, 71628, 71297, 71633, 71642, 71634, 71645, 71644, 71637, 71635, 71639, 71640, 71643, 71641, 71651, 71648, 71647, 71650, 71649, 71652, 71677, 71654, 71653, 71655, 71656, 71782, 71658, 71659, 71662, 71681, 71665, 71668, 71669, 71670, 71671, 42119, 71674, 71673, 71676, 71737, 71678, 71679, 71682, 71685, 71766, 71767, 71687, 71692, 71690, 71684, 71686, 71688, 71689, 71200, 71691, 71693, 71694, 42150, 71695, 71760, 71838, 71697, 71758, 71831, 71698, 71699, 71709, 42050, 71702, 71708, 71700, 71706, 71703, 71704, 71754, 71715, 71707, 71714, 71745, 71710, 71716, 71711, 71723, 71713, 71722, 71327, 71717, 71725, 71726, 71729, 71730, 71743, 71733, 71734, 71762, 42096, 71738, 71740, 71744, 71748, 71746, 85218, 71749, 71752, 71753, 71864, 71756, 42101, 71755, 71771, 42196, 71763, 71757, 85006, 71759, 71764, 71765, 71363, 71772, 71773, 71775, 71778, 71963, 71964, 71962, 71779, 71780, 71781, 71784, 71786, 71783, 71785, 71790, 71788, 71791, 71848, 71789, 71799, 71801, 71802, 71806, 71804, 42045, 71807, 71811, 71812, 71818, 71813, 71814, 71819, 71808, 71816, 71817, 71822, 71820, 71821, 71826, 71825, 71833, 85162, 85682, 71842, 71881, 71839, 71840, 71863, 71841, 71800, 71844, 71849, 71850, 71868, 71856, 71851, 71852, 71854, 71853, 71855, 71860, 71861, 71862, 71867, 71866, 71869, 71187, 71871, 71872, 71875, 71876, 71877, 71908, 71878, 71879, 71880, 71882, 71859, 71884, 71889, 71885, 71887, 71898, 71891, 71892, 71894, 71899, 71896, 71895, 42238, 71897, 71900, 71823, 71913, 71909, 71911, 71910, 85010, 71917, 71920, 71918, 71921, 71922, 71923, 71935, 71926, 71924, 71925, 71928, 71976, 71931, 71930, 42328, 71944, 71936, 71946, 71415, 71569, 71570, 71953, 71945, 42292, 71948, 71957, 71949, 71951, 71952, 71954, 71370, 71956, 71916, 71967, 71955, 71958, 71972, 71979, 71977, 42169, 71973, 71984, 71986, 71987, 71988, 71996, 71991, 71993, 71994, 85015, 71073, 85004, 71992, 71407, 71997, 71998, 71999, 85000, 85002, 71322, 85003, 85005, 85011, 85018, 85012, 85016, 85679, 85019, 85020, 85021, 85022, 85023, 85028, 85024, 85065, 85025, 42185, 85031, 85032, 85034, 42173, 85036, 85037, 85045, 85038, 85047, 85048, 85042, 85049, 85050, 85046, 85044, 42376, 71027, 85054, 85056, 85061, 85075, 85059, 85064, 71016, 85068, 85069, 85070, 85219, 85073, 71275, 71599, 85074, 85078, 85079, 85080, 85081, 85082, 85083, 85085, 85087, 85089, 85121, 85101, 85091, 85092, 85096, 85095, 85067, 85097, 85098, 85099, 85106, 85063, 85102, 85076, 85109, 85201, 85105, 85111, 85112, 71364, 71064, 85114, 85651, 85126, 71029, 85122, 85123, 85124, 85125, 85145, 85148, 85132, 85127, 85140, 71358, 85136, 85180, 85141, 85161, 85142, 85143, 85146, 85147, 85149, 85150, 85152, 85151, 85153, 85155, 85157, 71065, 85160, 71444, 85166, 85168, 85169, 85170, 85193, 85171, 85172, 85178, 85174, 85177, 71919, 85181, 85185, 85183, 85184, 85188, 85186, 85190, 85187, 71388, 85189, 71528, 85192, 85195, 85199, 85197, 85198, 85203, 71532, 85200, 85202, 85204, 85206, 85205, 85209, 42025, 85222, 71584, 85216, 85208, 85220, 85213, 71513, 85223, 85217, 85224, 85226, 85215, 85230, 85232, 85231, 85233, 42298, 85234, 85236, 85237, 85238, 85253, 85242, 85243, 71074, 85245, 85246, 85249, 85247, 71675, 71721, 85250, 71827, 85251, 71858, 85260, 85258, 85259, 85263, 85265, 85241, 71805, 85268, 85269, 85270, 85272, 85276, 85277, 85280, 71680, 85283, 71796, 85284, 85285, 71355, 85286, 85288, 85191, 85282, 85290, 85291, 85294, 85295, 85319, 71966, 85301, 85300, 85303, 85304, 85306, 85317, 85305, 85309, 85312, 85313, 85318, 85311, 85310, 85314, 85316, 85302, 85322, 85323, 85325, 85329, 85330, 85333, 85334, 85335, 85332, 85336, 85339, 85340, 85341, 85342, 85346, 85344, 85345, 85350, 85349, 85351, 85354, 85355, 85367, 85357, 85358, 85371, 85359, 85368, 85362, 85361, 85360, 85364, 85366, 85369, 85370, 85356, 85376, 85373, 85374, 85375, 85380, 85377, 85378, 85381, 85383, 85382, 85348, 85384, 85385, 85386, 85387, 85388, 85389, 85390, 85391, 85392, 85393, 85372, 85396, 85397, 85398, 85400, 85401, 85402, 85407, 85403, 85406, 85408, 85412, 85413, 85414, 85415, 85416, 85419, 85417, 85418, 85422, 85421, 85420, 85425, 85428, 85426, 85427, 85430, 85431, 85429, 85433, 85399, 85434, 85432, 85439, 85440, 85442, 85353, 85447, 85448, 85449, 85450, 85455, 85454, 85600, 85453, 85456, 85457, 85458, 85462, 85460, 85461, 85463, 85606, 85459, 85607, 85604, 85608, 85601, 85612, 85467, 85468, 85466, 85469, 85613, 85470, 85471, 85611, 85620, 85476, 85481, 85478, 85480, 85479, 71667, 85614, 85615, 85066, 85485, 85483, 85616, 85617, 85484, 85487, 85488, 85490, 85491, 85498, 85494, 85279, 85619, 85496, 85501, 85497, 85654, 85499, 85506, 85507, 85504, 85509, 85510, 85515, 85517, 85518, 85519, 42034, 85522, 85524, 85525, 85526, 85663, 85527, 85677, 85531, 85528, 85535, 85533, 71153, 85629, 85622, 85625, 85626, 85628, 85630, 85660, 85631, 85633, 85532, 85637, 85638, 85641, 85646, 85649, 85653, 85650, 85656, 85657, 85658, 85659, 85664, 85662, 85666, 85668, 85672, 85675, 85676, 85684, 85685, 85686, 85687, 85690, 85692, 85695, 85696, 85706, 85707, 85652, 85688, 42389, 85715, 71369, 85718.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 18 of 41

Ingenia 3.0T CX, Magnetic Resonance System.

Z-1567-2024

Recall number: Z-1567-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 342 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781271, 782105; UDI-DI 884838068452, 884838098312; Serial No. 78000, 78003, 78004, 78005, 78007, 78035, 78062, 78010, 78009, 78011, 78012, 78014, 78013, 78015, 78016, 78017, 78018, 78025, 78021, 78019, 78023, 78043, 78068, 78026, 78053, 78027, 78028, 78039, 78029, 78030, 78031, 78032, 78033, 78034, 78036, 78038, 78040, 78070, 78042, 78044, 78045, 78082, 78046, 78047, 78048, 78049, 78051, 78115, 78050, 78008, 78058, 78059, 78060, 78063, 78064, 78065, 78067, 78066, 78071, 78072, 78073, 78074, 78075, 78076, 78077, 78078, 78080, 78081, 78083, 78084, 78086, 78087, 78088, 78089, 78091, 78092, 78094, 78095, 78101, 78096, 78097, 78099, 78098, 78100, 78102, 78113, 78114, 78109, 78103, 78104, 78106, 78107, 78110, 78117, 78112, 78118, 78111, 78120, 78129, 78121, 78122, 78123, 78126, 78127, 78128, 78132, 78133, 78135, 78138, 78137, 78139, 78140, 78141, 78142, 78145, 78149, 78147, 78148, 78150, 78151, 78154, 78155, 78156, 78158, 78162, 78164, 78166, 78167, 78157, 78171, 78173, 78172, 78175, 78161, 78170, 78180, 78182, 78183, 78186, 78187, 78188, 78223, 78189, 78190, 78193, 78194, 78195, 78196, 78197, 78198, 78199, 78201, 78202, 78022, 78203, 78206, 78181, 78207, 78208, 78209, 78210, 78205, 78213, 78212, 78214, 78215, 78221, 78216, 78217, 78218, 78240, 78219, 78222, 78224, 78227, 78229, 78225, 78232, 78233, 78234, 78235, 78239, 78242, 78243, 78241, 78244, 78247, 78249, 78250, 78251, 78252, 78254, 78253, 78255, 78256, 78259, 78263, 78260, 78261, 78262, 78266, 78264, 78265, 78238, 78267, 78268, 78273, 78269, 78270, 78271, 78272, 78280, 78281, 78277, 78279, 78283, 78282, 78284, 78286, 78287, 78288, 78289, 78290, 78293, 78294, 78291, 78292, 78257, 78295, 78297, 78296, 78298, 78299, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78316, 78317, 78314, 78319, 78320, 78321, 78322, 78323, 78324, 78326, 78328, 78327, 78329, 78330, 78332, 78333, 78334, 78335, 78336, 78339, 78340, 78337, 78338, 78341, 78342, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78501, 78364, 78359, 78363, 78361, 78360, 78362, 78366, 78503, 78500, 78504, 78368, 78508, 78505, 78513, 78512, 78507, 78370, 78377, 78374, 78375, 78376, 78386, 78516, 78517, 78518, 78519, 78524, 78522, 78523, 78521, 78525, 78526, 78527, 78531, 78529, 78530, 78532, 78533, 78535, 78536, 78537, 78538, 78539, 78540, 78543, 78542, 78544, 78545, 78546, 78547, 78548, 78549, 78550, 78553, 78554, 78560, 78561, 78557, 78556, 78559, 78562, 78564, 78565, 78566, 78567.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 19 of 41

Ingenia Ambition S, Magnetic Resonance System.

Z-1568-2024

Recall number: Z-1568-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 344 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 782133, 782139, 781359, 782108; UDI-DI 884838090057, 884838098343, 884838108639; Serial No. 48646, 48700, 48237, 48665, 48179, 48120, 48645, 48252, 48217, 48648, 48708, 48162, 48688, 48035, 48656, 48287, 48719, 48552, 48286, 48588, 48608, 48669, 48015, 48171, 48749, 48274, 48052, 48000, 48001, 48003, 48535, 48004, 48005, 48009, 48011, 48010, 48012, 48014, 48018, 48016, 48017, 48019, 48022, 48023, 48032, 48026, 48030, 48034, 48037, 48036, 48020, 48040, 48044, 48038, 48043, 48129, 48045, 48046, 48047, 48049, 48050, 48028, 48051, 48053, 48055, 48056, 48122, 48027, 48233, 48128, 48131, 48126, 48127, 48133, 48132, 48039, 48135, 48136, 48308, 48309, 48290, 48165, 48148, 48163, 48145, 48152, 48151, 48178, 48153, 48158, 48170, 48167, 48169, 48155, 48173, 48314, 48174, 48154, 48177, 48160, 48180, 48144, 48181, 48182, 48134, 48185, 48183, 48184, 48187, 48186, 48190, 48192, 48194, 48219, 48196, 48172, 48254, 48200, 48199, 48198, 48207, 48191, 48031, 48188, 48222, 48223, 48253, 48224, 48242, 48248, 48275, 48225, 48226, 48236, 48033, 48234, 48285, 48216, 48238, 48239, 48240, 48241, 48244, 48249, 48250, 48245, 48268, 48013, 48269, 48271, 48272, 48504, 48503, 48500, 48502, 48501, 48276, 48278, 48506, 48507, 48505, 48283, 48508, 48284, 48510, 48521, 48512, 48585, 48288, 48513, 48617, 48514, 48515, 48519, 48520, 48522, 48530, 48293, 48524, 48525, 48526, 48297, 48534, 48299, 48300, 48303, 48302, 48291, 48112, 48218, 48304, 48536, 48537, 48539, 48538, 48544, 48540, 48529, 48711, 48550, 48551, 48313, 48556, 48316, 48555, 48130, 48294, 48558, 48214, 48560, 48602, 48561, 48541, 48166, 48566, 48572, 48564, 48574, 48273, 48567, 48569, 48568, 48576, 48600, 48591, 48571, 48573, 48322, 48580, 48582, 48590, 48592, 48593, 48594, 48597, 48317, 48606, 48604, 48610, 48243, 48609, 48611, 48613, 48649, 48614, 48620, 48622, 48627, 48624, 48326, 48628, 48578, 48331, 48616, 48337, 48639, 48641, 48642, 48644, 48523, 48647, 48546, 48652, 48164, 48584, 48661, 48662, 48663, 48581, 48664, 48666, 48667, 48668, 48672, 48615, 48673, 48676, 48562, 48632, 48685, 48687, 48589, 48549, 48577, 48579, 48686, 48693, 48699, 48695, 48698, 48694, 48697, 48629, 48329, 48638, 48660, 48595, 48707, 48659, 48714, 48658, 27511, 48680, 48548, 48635, 48570, 48721, 48725, 48651, 48726, 48586, 48728, 48734, 48715, 48738, 48744, 48762, 48768, 48679, 48775, 48778, 48781, 48612, 48607, 48800, 48806, 48810, 48813, 48819, 48818, 48710, 48833, 29010, 29000, 29011, 48804, 48729, 29013, 29012, 29014, 29017, 48769, 48640, 48817.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 20 of 41

Ingenia Ambition X, Magnetic Resonance System.

Z-1569-2024

Recall number: Z-1569-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 404 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781359, 782109, 782138; UDI-DI 884838090040, 884838098350, 884838108622; Serial No. 47199, 47290, 47387, 47062, 47325, 47038, 47554, 47043, 47004, 47278, 47323, 47027, 47542, 47794, 47045, 47336, 47331, 47282, 47093, 47185, 47606, 47183, 47090, 47198, 47324, 47210, 47862, 47700, 47216, 47066, 47029, 47322, 47051, 47028, 47203, 47659, 47335, 47253, 47289, 47022, 47351, 47759, 47044, 47063, 47061, 47054, 47377, 47316, 47371, 47370, 47380, 47007, 47196, 47204, 47303, 47305, 47026, 47006, 47291, 47672, 47084, 47260, 47294, 47025, 47339, 47802, 47621, 47095, 47279, 47726, 47569, 47237, 47208, 47033, 47703, 47575, 47541, 47668, 47534, 47098, 47003, 47002, 47000, 47001, 47035, 47205, 47344, 47009, 47012, 47016, 47013, 47015, 47070, 47017, 47019, 47020, 47209, 47024, 47030, 47023, 47034, 47032, 47040, 47041, 47050, 47353, 47048, 47047, 47049, 47052, 47058, 47056, 47057, 47059, 47064, 47074, 47072, 47075, 47078, 47077, 47083, 47080, 47081, 47085, 47088, 47089, 47094, 47091, 47177, 47092, 47280, 47053, 47096, 47014, 47099, 47097, 47338, 47175, 47174, 47184, 47222, 47245, 47187, 47189, 47192, 47065, 47188, 47190, 47215, 47200, 47211, 47195, 47193, 47197, 47194, 47082, 47202, 47207, 47254, 47219, 47220, 47221, 47225, 47558, 47227, 47226, 47230, 47231, 47246, 47247, 47242, 47244, 47248, 47292, 47252, 47337, 47255, 47258, 47039, 47262, 47269, 47264, 47274, 47271, 47293, 47268, 47270, 47276, 47275, 47283, 47281, 47286, 47299, 47284, 47302, 47288, 47513, 47307, 47297, 47602, 47298, 47301, 47272, 47312, 47310, 47304, 47306, 47309, 47311, 47313, 47314, 47315, 47328, 47329, 47332, 47342, 47071, 47341, 47037, 47502, 47504, 47503, 47345, 47505, 47507, 47508, 47350, 47521, 47352, 47511, 47356, 47512, 47514, 47516, 47560, 47509, 47522, 47559, 47539, 47518, 47517, 47519, 47525, 47520, 47523, 47526, 47527, 47528, 47529, 47530, 47666, 47667, 47531, 47364, 47533, 47365, 47532, 47367, 47535, 47536, 47540, 47060, 47576, 47543, 47588, 47545, 47546, 47548, 47547, 47067, 47549, 47550, 47552, 47555, 47553, 47361, 47677, 47577, 47561, 47562, 47563, 47068, 47564, 47565, 47570, 47340, 47578, 47382, 47642, 47579, 47583, 47330, 47582, 47584, 47585, 47591, 47597, 47702, 47594, 47557, 47384, 47595, 47596, 47607, 47603, 47206, 47385, 47233, 47612, 47614, 47615, 47617, 47622, 47538, 47623, 47346, 47634, 47635, 47851, 47640, 47644, 47646, 47755, 47684, 47656, 47333, 47657, 47665, 47660, 47662, 47678, 47669, 47568, 47671, 47567, 47572, 47800, 47680, 47580, 47679, 47687, 47598, 47681, 47599, 47685, 47683, 47566, 47815, 47688, 47695, 47694, 47762, 47697, 47701, 47589, 47705, 47706, 47708, 47709, 47711, 47710, 47716, 47718, 47721, 47723, 47722, 47724, 47733, 47347, 47729, 47761, 47608, 47737, 47781, 47742, 47732, 47648, 47011, 47748, 47753, 47018, 47785, 47786, 47378, 47610, 47738, 47798, 47674, 47811, 47651, 49002, 49000, 49003, 47652, 47717, 47848, 47661, 49013, 47663, 47348, 47728, 47731, 47747, 47730.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 21 of 41

Ingenia Elition S, Magnetic Resonance System.

Z-1570-2024

Recall number: Z-1570-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 131 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781357, 782106; UDI-DI 884838088108, 884838098329; Serial No. 46065, 46071, 46077, 46025, 46224, 46005, 46003, 46001, 46008, 46004, 46007, 46032, 46011, 46012, 46013, 46015, 46016, 46017, 46019, 46021, 46002, 46018, 46020, 46023, 46024, 46046, 46026, 46027, 46029, 46030, 46031, 46033, 46109, 46034, 46036, 46039, 46037, 46052, 46041, 46042, 46045, 46088, 46050, 46048, 46049, 46058, 46053, 46055, 46054, 46061, 46060, 46057, 46014, 46059, 46044, 46067, 46066, 46068, 46069, 46075, 46076, 46078, 46081, 46082, 46084, 46086, 46083, 46085, 46089, 46104, 46094, 46092, 46101, 46093, 46095, 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46107, 46208, 46207, 46209, 46211, 46217, 46213, 46214, 46215, 46218, 46111, 46219, 46220, 46222, 46226, 46258, 46231, 46228, 46233, 46235, 46237, 46239, 46249, 46240, 46241, 46242, 46234, 46243, 46245, 46247, 46119, 46268, 46097, 46282, 46289, 46305, 46304, 46263, 46310, 46121, 46315, 46265, 46269, 46270, 46325, 46324, 46331, 46338, 46352.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 22 of 41

Ingenia Elition X, Magnetic Resonance System.

Z-1571-2024

Recall number: Z-1571-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 448 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 782136, 781358, 78217, 782119; UDI-DI 884838108622, 884838098336, 884838104129, 884838108608; Serial No. 45051, 45423, 45238, 45264, 45194, 45357, 45113, 45322, 45353, 45269, 45252, 45235, 45178, 45164, 45316, 45010, 45356, 45060, 45055, 45002, 45570, 45429, 45364, 45343, 45236, 45075, 45398, 45146, 45099, 45027, 45011, 45100, 45068, 45247, 45112, 45395, 66001, 45261, 45315, 45024, 45032, 45133, 45277, 45152, 45243, 45355, 45161, 45150, 45245, 45132, 45000, 45237, 45008, 45028, 45030, 45025, 45031, 45033, 45036, 45034, 45037, 45039, 45040, 45041, 45042, 45044, 45043, 45045, 45046, 45047, 45048, 45049, 45050, 45052, 45109, 45056, 45061, 45062, 45070, 45064, 45065, 45067, 45066, 45029, 45072, 45080, 45076, 45058, 45077, 45088, 45081, 45111, 45084, 45082, 45085, 45090, 45096, 45091, 45093, 45095, 45094, 45097, 45009, 45098, 45102, 45079, 45105, 45107, 45114, 45115, 45116, 45118, 45119, 45128, 45106, 45120, 45134, 45122, 45123, 45127, 45129, 45136, 45137, 45140, 45121, 45138, 45139, 45141, 45142, 45144, 45145, 45148, 45149, 45131, 45155, 45151, 45157, 45156, 45154, 45160, 45153, 45158, 45159, 45162, 45163, 45165, 45168, 45170, 45171, 45174, 45176, 45177, 45263, 45180, 45181, 45187, 45169, 45183, 45184, 45185, 45186, 45193, 45188, 45190, 45189, 45195, 45191, 45197, 45203, 45204, 45205, 45207, 45262, 45218, 45210, 45035, 45231, 45294, 45211, 45212, 45321, 45217, 45216, 45219, 45026, 45108, 45220, 45222, 45224, 45227, 45229, 45228, 45078, 45242, 45253, 45244, 45248, 45246, 45260, 45249, 45250, 45192, 45259, 45265, 45280, 45267, 45268, 45374, 45274, 45276, 45272, 45340, 45241, 45282, 45278, 45279, 45281, 45289, 45284, 45317, 45290, 45319, 45293, 45295, 45298, 45300, 45311, 45312, 45313, 45314, 45302, 45320, 45323, 45350, 45328, 45330, 45333, 45053, 45332, 45339, 45054, 45342, 45348, 45349, 45344, 45345, 45352, 45354, 45500, 45359, 45360, 45362, 45257, 45363, 45503, 45368, 45367, 45369, 45371, 45372, 45370, 45376, 45504, 45379, 45507, 45382, 45381, 45508, 45377, 45506, 45378, 45501, 45392, 45509, 45510, 45518, 45517, 45511, 45514, 45540, 45516, 45124, 45390, 45089, 45391, 45147, 45519, 45520, 45521, 45572, 45523, 45524, 45525, 45583, 45393, 45528, 45531, 45530, 45532, 45394, 45406, 45407, 45533, 45534, 45536, 45542, 45397, 45396, 45554, 45538, 45409, 45543, 45412, 45410, 45544, 45411, 45546, 45545, 45547, 45417, 45416, 45550, 45419, 45421, 45432, 45426, 45552, 45556, 45555, 45428, 45559, 45560, 45408, 45561, 45434, 45435, 45562, 45437, 45564, 45439, 45565, 45566, 45568, 45441, 45442, 45563, 45573, 45574, 45337, 45444, 45578, 45577, 45446, 45580, 45338, 45448, 45447, 45296, 45589, 45451, 45594, 45595, 45596, 62011, 62012, 45335, 45600, 45567, 45599, 62018, 62017, 45459, 62021, 45463, 45414, 62023, 62024, 45461, 62031, 62033, 45467, 62035, 45469, 62038, 62039, 62040, 62041, 62042, 62044, 45470, 62046, 62051, 62052, 62056, 45473, 62063, 62061, 45474, 62066, 62019, 62070, 62071, 45471, 45450, 62073, 45456, 62016, 62087, 62081, 62083, 62080, 62082, 45476, 62091, 45480, 62097, 62088, 62124, 62113, 62103, 62104, 62164, 62108, 62111, 45086, 62120, 62126, 62137, 62129, 45087, 62134, 62148, 62147, 62154, 62162, 62173, 62176, 66002, 28509, 28507, 28502, 62188, 62114, 62118, 62186, 62047, 62092, 62050.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 23 of 41

Intera 0.5T Standard, Magnetic Resonance System.

Z-1572-2024

Recall number: Z-1572-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781101; UDI-DI n/a; Serial No. 6047, 6018, 6023, 6027, 6031, 6044, 6060, 10306, 6015, 6061, 6025, 6054, 6001, 6066.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 24 of 41

Intera 1.0T Omni/Stellar, Magnetic Resonance System.

Z-1573-2024

Recall number: Z-1573-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781102; UDI-DI n/a; Serial No. 7069, 7213, 7238, 10045, 7248, 10341, 10073, 7020, 7247, 7081, 7141, 7120, 7116, 10334, 10047, 7226, 7111, 7203, 7117, 7022, 7031, 7085, 7051, 7156, 7215, 10001, 10328, 7018.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 25 of 41

Intera 1.0T Power/Pulsar, Magnetic Resonance System.

Z-1574-2024

Recall number: Z-1574-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781103; UDI-DI n/a; Serial No. 7062, 7164, 7102, 7113, 7084, 10381, 7097, 10383, 10384, 10391, 7150, 7074, 7237, 7190, 7198, 10413, 10382, 7103, 10071.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 26 of 41

Intera 1.5T, Magnetic Resonance System.

Z-1575-2024

Recall number: Z-1575-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 347 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781195, 781295; UDI-DI n/a; Serial No. 30030, 18972, 18784, 18616, 18668, 18901, 30047, 18868, 18822, 18974, 18607, 18864, 18861, 18966, 18566, 18586, 18580, 18618, 18664, 18612, 18734, 18611, 18647, 18637, 30029, 18681, 18504, 18694, 18501, 18527, 18646, 18719, 18680, 18705, 18639, 18716, 18748, 18743, 18727, 18752, 18675, 18759, 18768, 18796, 18805, 18772, 18813, 18794, 18798, 18854, 18766, 18873, 18535, 18544, 18557, 18698, 18711, 18730, 18765, 18773, 18774, 18781, 18820, 18870, 18877, 18886, 18885, 18536, 18856, 18888, 18908, 18890, 18871, 18887, 18907, 18917, 18897, 18923, 18899, 18914, 18931, 18895, 18898, 18941, 18944, 18946, 18905, 18927, 18916, 18952, 18953, 18967, 18833, 18896, 18964, 18958, 18980, 18984, 18987, 18971, 18977, 18949, 18962, 18991, 18997, 20409, 18989, 20412, 20402, 18999, 20414, 18919, 20415, 20426, 20427, 20429, 18976, 20431, 18951, 18937, 30038, 30036, 30053, 30043, 30061, 30058, 30064, 18982, 18981, 30065, 20439, 30062, 30055, 30035, 30075, 30083, 30070, 20424, 30101, 30052, 30107, 20441, 30100, 30104, 30105, 30109, 30102, 30106, 30099, 30113, 30114, 30115, 30116, 30120, 30122, 30123, 30125, 30128, 30130, 30134, 30133, 30142, 30137, 30140, 30143, 30131, 30119, 30135, 30145, 30148, 18842, 18654, 18995, 30051, 30084, 30149, 30095, 30118, 30152, 30154, 30153, 30155, 30138, 30158, 30159, 30160, 30162, 30028, 30163, 30164, 30169, 30167, 30168, 30171, 30173, 30174, 18763, 30175, 30176, 30177, 30178, 30179, 30180, 30182, 30181, 30183, 30184, 30185, 30188, 30186, 30187, 30190, 30189, 30191, 30192, 30196, 30170, 30198, 30203, 30206, 30208, 30213, 30214, 30215, 30216, 30217, 30218, 30219, 30220, 30221, 30209, 30222, 30197, 30223, 30226, 30227, 30201, 30228, 30230, 30231, 30232, 30233, 30234, 30235, 30237, 30240, 30241, 30242, 18516, 30243, 30244, 18939, 30245, 30246, 30250, 30248, 30249, 30251, 30252, 30253, 30254, 30256, 30259, 30263, 30262, 30264, 18593, 30261, 30270, 30266, 30267, 30268, 30269, 30272, 30276, 30277, 30279, 30281, 30283, 30284, 30285, 30287, 18569, 30207, 30288, 30289, 30290, 30291, 30294, 30210, 30199, 30200, 30280, 30265, 30297, 30298, 30304, 30293, 30307, 30308, 30282, 30306, 30309, 30310, 30311, 18517, 18708, 18554, 30314, 30315, 30059, 18579, 18546, 30017, 18876, 18539, 30302, 18628, 18725, 18749, 18660, 18723, 18669, 18678, 18542, 18674, 18738, 18534, 18667, 30098, 18973, 18904, 30063, 18657, 20400, 30091, 18932, 18740, 18850, 18875, 18920, 30094, 18755, 18947, 18659, 18538, 18739.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 27 of 41

Intera 1.5T Achieva IT Nova, Magnetic Resonance System.

Z-1576-2024

Recall number: Z-1576-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781175; UDI-DI n/a; Serial No. 15002, 15003.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 28 of 41

Intera 1.5T Achieva Nova, Magnetic Resonance System.

Z-1577-2024

Recall number: Z-1577-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781172; UDI-DI n/a; Serial No. 12144, 12075, 12031, 12015, 12056, 12051, 12107, 12078, 12065, 12045, 12046, 12026, 12105, 12062, 12111, 12077, 12044, 12049, 12119, 12081, 12161, 12099, 12138, 12020, 12139, 12102, 12069, 12152, 12004, 12086, 12122, 12128, 12052, 12063, 12005, 12050, 12141, 12025, 12106, 12146, 12001, 11010, 12074, 12073, 12079, 12057.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 29 of 41

Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.

Z-1578-2024

Recall number: Z-1578-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781173; UDI-DI n/a; Serial No. 13010, 13013, 13028, 13017, 13033, 13058, 13061, 13071, 13056, 13074, 13057, 13044, 13060, 13027, 13067, 13049, 13048, 13043, 13008, 13012.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 30 of 41

Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.

Z-1579-2024

Recall number: Z-1579-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781108; UDI-DI n/a; Serial No. 8918, 10035, 8803, 10037, 9025, 10022, 10638, 10640, 8743, 8651, 10091, 8690.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 31 of 41

Intera 1.5T Master/Nova, Magnetic Resonance System.

Z-1580-2024

Recall number: Z-1580-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 107 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781106; UDI-DI n/a; Serial No. 8648, 8650, 8400, 8668, 8849, 8788, 8754, 8603, 8733, 8488, 8928, 8866, 8224, 8368, 8254, 10131, 8379, 8827, 8482, 8050, 8018, 8356, 8205, 8362, 8800, 8793, 8437, 8313, 8924, 9023, 10134, 10016, 8984, 8325, 8248, 8947, 8479, 8195, 8940, 10536, 10567, 8364, 9028, 8593, 8136, 10059, 8448, 8345, 8363, 8678, 9018, 8775, 8423, 8410, 8013, 8259, 8700, 8284, 8955, 8539, 10556, 8547, 8980, 8720, 8565, 8858, 8672, 8373, 10568, 8177, 8150, 8501, 9015, 8317, 8941, 8265, 8901, 10197, 8744, 10094, 8360, 8295, 10110, 8915, 8429, 8226, 8976, 8726, 8160, 8214, 8444, 9014, 8564, 8134, 8009, 8159, 10133, 8908, 8152, 10195, 8071, 8324, 8147, 8161, 8606, 8173, 8068.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 32 of 41

Intera 1.5T Omni/Stellar, Magnetic Resonance System.

Z-1581-2024

Recall number: Z-1581-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781104; UDI-DI n/a; Serial No. 8483, 8526, 8257, 8171, 8731, 8126, 10403, 10401, 10410, 10407, 8266, 8286, 8246, 8725, 8556, 8338, 8625, 8516, 8332, 8138, 8921, 8359.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 33 of 41

Intera 1.5T Power/Pulsar, Magnetic Resonance System.

Z-1582-2024

Recall number: Z-1582-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 115 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781105; UDI-DI n/a; Serial No. 8342, 8104, 8899, 8557, 8797, 8665, 8154, 8590, 8333, 8418, 8615, 8963, 8846, 8216, 8112, 8296, 8384, 8626, 8093, 8217, 10209, 10093, 8738, 10212, 8622, 8040, 8748, 8695, 8188, 8326, 8684, 8854, 8878, 8936, 8974, 8935, 10156, 10140, 8337, 10510, 10920, 10488, 10517, 8588, 8158, 8405, 8610, 8017, 10479, 8381, 9003, 10163, 10470, 9027, 8032, 8207, 8280, 8283, 8293, 8439, 8618, 8688, 10232, 8838, 8605, 10120, 10129, 8420, 10080, 8546, 8548, 8434, 10500, 10187, 9029, 8676, 8836, 8685, 8469, 8505, 8470, 8277, 8991, 8510, 8633, 8357, 8048, 10159, 8643, 8414, 8708, 8925, 8130, 8617, 8818, 8027, 10039, 8335, 8952, 8663, 8549, 8034, 10108, 8956, 8806, 8916, 8791, 8393, 8058, 8455, 8033, 8558, 8579, 10178, 10526.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 34 of 41

Intera 1.5T R11, Magnetic Resonance System.

Z-1583-2024

Recall number: Z-1583-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781170; UDI-DI n/a; Serial No. 18070, 18021, 18025, 18110, 18019, 18009, 18055, 18064, 18095, 18105, 18002, 18082, 18083, 18039, 18108, 18032, 18071, 18092, 18074, 18030, 18011, 18049, 18066, 18097, 18031.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 35 of 41

Intera 3.0T Quasar Dual, Magnetic Resonance System.

Z-1584-2024

Recall number: Z-1584-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781150; UDI-DI n/a; Serial No. 5729, 10138, 10123, 10746, 10136, 10103, 5714, 10182, 5704.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 36 of 41

Intera Achieva 1.5T Pulsar, Magnetic Resonance System.

Z-1585-2024

Recall number: Z-1585-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781171; UDI-DI n/a; Serial No. 11069, 11024, 11048, 11090, 11049, 11058, 11013, 11036, 11045, 11087, 11061, 11009, 11060, 11044, 11039, 11043, 11020, 11007, 11025, 11094, 11033, 11059, 11019, 11068.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 37 of 41

Intera CV, Magnetic Resonance System.

Z-1586-2024

Recall number: Z-1586-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781107; UDI-DI n/a; Serial No. 8528, 8653, 8907, 8869, 8703, 9017, 8756, 8014.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 38 of 41

MR 5300, Magnetic Resonance System.

Z-1587-2024

Recall number: Z-1587-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 166 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 782110; UDI-DI 884838099364; Serial No. 63029, 63087, 63014, 63103, 63000, 63006, 63007, 63001, 63008, 63010, 63013, 63015, 63021, 63022, 63039, 63023, 63024, 63026, 63025, 63028, 63030, 63031, 63038, 63054, 63041, 63042, 63046, 63043, 63044, 63047, 63049, 63050, 63012, 63051, 63053, 63032, 63057, 63060, 63094, 63064, 63063, 63068, 63079, 63066, 63072, 63071, 63070, 63082, 63074, 63076, 63083, 63202, 63085, 63019, 63086, 63093, 63091, 63090, 63096, 63097, 63165, 63075, 63099, 63104, 63106, 63105, 63108, 63009, 63107, 63109, 63111, 63112, 63119, 63115, 63116, 63127, 63121, 63125, 63069, 63034, 63130, 63036, 63058, 63155, 63144, 63140, 63141, 63146, 63033, 63149, 63151, 63150, 63153, 63154, 63157, 63161, 63080, 63098, 63018, 63166, 63169, 63175, 63176, 63178, 63177, 63191, 63197, 63188, 63183, 63186, 63187, 63198, 63195, 63199, 63262, 63210, 63148, 63223, 63224, 63239, 63228, 63229, 63128, 63261, 63260, 63122, 63243, 63248, 63252, 63027, 63266, 63267, 63268, 63276, 63271, 63283, 63287, 63286, 63306, 63272, 63292, 63309, 63135, 63311, 63078, 63190, 63174, 63201, 63331, 63168, 63139, 63290, 63220, 63288, 63304, 63264, 63138, 63402, 63016, 63270, 63305, 63282, 63285, 63265, 63289, 63303.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 39 of 41

MR 7700, Magnetic Resonance System.

Z-1588-2024

Recall number: Z-1588-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 782120; UDI-DI 884838104112; Serial No. 65051, 65005, 65000, 65002, 65003, 65001, 65004, 65009, 65012, 65013, 65015, 65017, 65020, 65019, 65021, 65023, 65024, 65025, 65031, 65006, 65032, 65035, 65034, 65038, 65030, 65037.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 40 of 41

SmartPath to dStream for 1.5T, Magnetic Resonance System.

Z-1589-2024

Recall number: Z-1589-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 672 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781260, 782112; UDI-DI 884838095076, 884838098886; Serial No. 8954, 18726, 32174, 21664, 8906, 8578, 10703, 8835, 10154, 8971, 20226, 9001, 21665, 20204, 21108, 5475, 12033, 39024, 10196, 32131, 8630, 12034, 8772, 8091, 21555, 21294, 18561, 18761, 10482, 18800, 22285, 8560, 21788, 11064, 30146, 8100, 10036, 13052, 21023, 21290, 32094, 21223, 10717, 32142, 12134, 5572, 8378, 21003, 39103, 8566, 8190, 5523, 10511, 21611, 21612, 21888, 32184, 12084, 39003, 10079, 20198, 13032, 20071, 8642, 8318, 72054, 10170, 8178, 10174, 9022, 8087, 8923, 21438, 8591, 21033, 13018, 11030, 8119, 18665, 8427, 10061, 8895, 8706, 21253, 5511, 8601, 18808, 18655, 22060, 8608, 8352, 8481, 5490, 5479, 8819, 39005, 8118, 11031, 8857, 10915, 11042, 10544, 8948, 21019, 32450, 18663, 8646, 8884, 22098, 32506, 22127, 13062, 21175, 10075, 18801, 10164, 10498, 21880, 18690, 22299, 20111, 21050, 5466, 8084, 13047, 10029, 21142, 8611, 8395, 8311, 8786, 8215, 9013, 8554, 12115, 8783, 8260, 8478, 13011, 8639, 9004, 10139, 5546, 8387, 8896, 22154, 21278, 10191, 21129, 32221, 32218, 32449, 32443, 32445, 32444, 11085, 18644, 21067, 72243, 9007, 8712, 8942, 10183, 8667, 12030, 5463, 21912, 12114, 18038, 5537, 13029, 8025, 18101, 10457, 8750, 8752, 10044, 11091, 21498, 12072, 11062, 32311, 21554, 8057, 8779, 8746, 12055, 13069, 8559, 18565, 8309, 21156, 32147, 32410, 11046, 10554, 18511, 10220, 20057, 21481, 21679, 11102, 18631, 8200, 32849, 32513, 9006, 18610, 10906, 10130, 8086, 21560, 32264, 8804, 8021, 5447, 21697, 10513, 20033, 20302, 8831, 18970, 21676, 8840, 32180, 21084, 11076, 32374, 32742, 8330, 21015, 32621, 18512, 20112, 8392, 21458, 21184, 32361, 32140, 33126, 32492, 13046, 21759, 8365, 10900, 39037, 8641, 8060, 13001, 10185, 32405, 32643, 21466, 32200, 30037, 10719, 10086, 22107, 11000, 32176, 8407, 22342, 32752, 8240, 10913, 10570, 21062, 21942, 33100, 11001, 18509, 18035, 18697, 8531, 8512, 8985, 10523, 20319, 10151, 18060, 8010, 18558, 20151, 20152, 32710, 5505, 18597, 8354, 10033, 10716, 18673, 18701, 22189, 8704, 32636, 8129, 18069, 5539, 12036, 11072, 32438, 21691, 21171, 39031, 8251, 32092, 8263, 8397, 21680, 8156, 18929, 21392, 10179, 20002, 33051, 12047, 21623, 21969, 32391, 20322, 22102, 11108, 8843, 21929, 20116, 13082, 32127, 32113, 20237, 32341, 5499, 22055, 32990, 30067, 20011, 18107, 8760, 20278, 8983, 32754, 8305, 20003, 21349, 20195, 22296, 21355, 8723, 21384, 21591, 22103, 32822, 21748, 32334, 20211, 32245, 8913, 8713, 21222, 21011, 8168, 18746, 8292, 18704, 8110, 11005, 20164, 22013, 21987, 21551, 11017, 22301, 8094, 21583, 8561, 20209, 8451, 10543, 21780, 22100, 22137, 32296, 18938, 21694, 18957, 32049, 20187, 22220, 8711, 21640, 21182, 21403, 21213, 21804, 18720, 8887, 21209, 12120, 21579, 22070, 10552, 21519, 10007, 18524, 32454, 21736, 9020, 8550, 21448, 11018, 22227, 21141, 21477, 72081, 18699, 12082, 20196, 18954, 21249, 11100, 30097, 8736, 20115, 8885, 33220, 9024, 21018, 21892, 22194, 8074, 21362, 21768, 21814, 32680, 32807, 21621, 32283, 8492, 8862, 21775, 32099, 32163, 10117, 5484, 22184, 18853, 8315, 18017, 8657, 8476, 8401, 32573, 18906, 22144, 21453, 33352, 33023, 8694, 18985, 32145, 18986, 10530, 20413, 8045, 18583, 33062, 22237, 18013, 22248, 8975, 32467, 32059, 72239, 32217, 18948, 22157, 8517, 21082, 32258, 8486, 5536, 21710, 39009, 21247, 22044, 18575, 22347, 22175, 8321, 21133, 32164, 18718, 20035, 10008, 21089, 22123, 8175, 10528, 18894, 21890, 21577, 21326, 5425, 39018, 32340, 32119, 32322, 10102, 13023, 21127, 21809, 32236, 32845, 32478, 8096, 30132, 21979, 8213, 32132, 33385, 32778, 32285, 22031, 18559, 32286, 10161, 8456, 32839, 12121, 22266, 32923, 20165, 32134, 32262, 10461, 13026, 21359, 18965, 18851, 32953, 8166, 21792, 33106, 22255, 22257, 22256, 21333, 20182, 33215, 33366, 32359, 12009, 21138, 33044, 22152, 9032, 18548, 5550, 32670, 18574, 8424, 30239, 18788, 18988, 32333, 21746, 32316, 18670, 21671, 20160, 30033, 30139, 21994, 32458, 72250, 21995, 33246, 18803, 33716, 12053, 8798, 10169, 8109, 21212, 32798, 32803, 32804, 8573, 21298, 33179, 72275, 21684, 32719, 18998, 75012, 33019, 22298, 21090, 21433, 18950, 21685, 10040, 30031, 8734, 21379, 32580, 32577, 32041, 32661, 20099, 22290, 8808, 12029, 10028, 21893, 30089, 32457, 33565, 12002, 8766, 32158, 32827, 33546, 32426, 10190, 18857, 18776, 32725, 21608, 33082, 32709, 32696, 22027, 22267, 32355, 8298, 32539, 21513, 22048, 10521, 10128, 21164, 13021, 21940, 39106, 18520, 39070, 32844, 32378, 18892, 33639, 21158, 32412, 20159, 30054, 21740, 21726, 18942, 33371, 33103, 32133, 8876, 32724, 22247, 32419, 32349, 10222, 32363, 33404, 33217, 33033, 32327, 32364.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

device · product 41 of 41

SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.

Z-1590-2024

Recall number: Z-1590-2024
Initiated: March 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Patient support table floor plate may be incorrectly installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Patient support table floor plate may be incorrectly installed.

Code information

Model No. 781270, 782113, 782129; UDI-DI 884838098909, 884838105805; Serial No. 17271, 38281, 17560, 17252, 34202, 34153, 34127, 38311, 34128, 34172, 17470, 34131, 24021, 24093, 17258, 38290, 35041, 38105, 34110, 17449, 38010, 34212, 38142, 34117, 38166, 38106, 34129, 38310, 38195, 38219, 24077, 24039, 38222, 17521, 34072, 38117, 38070, 34055, 17439, 17455, 38075.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

Event summary

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Every recalled product in this event

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