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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83811

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 03, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Achilles Insight Bone Sonometer

Z-0112-2020
Recall number
Z-0112-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
599 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

Code information

System ID: AWI33021, AWI33682, 0911LN0007, 091133NZM31481, 091133NZM31582, 091133NZM31875, BH1055US01, 0002860952, 0002868705, 83033603652009, 83033604564999, 0002657156, ACH+12941, ACH+12946, 084733NZM31677, 2644078, 82433040028, 82433040037, 82433070008, 82433120015, 82433080005, 82433040035, 82433040039, 82433140020, 82433290005, 82433130044, 82433130045, 82433230011, 82433140022, 82433140023, 82433140021, 82433140016, 0002556007X, CY1121US01, 828330064, 828330102, 828330049, 828330082, 83033005100157, 0002752556, 83033825104417, 83033205101815, 83033209010045, IQ1287US02, IQ1084US01, IE1016LU04, IE1063LU02, IE1106LU02, IE1106LU03, IE1153US01, IE1131US01, A6165801, A185446001, A6141901, A5945702, B5313202, A6141801, A5807032, A167409101, A6089201, A156115001, A6091501, B5481117, A5314930, B5715201, B5715202, A6143401, A6082001, B120559406, A6141601, A5997501, A5959302, C5120921, A5250606, A144165602, A6122001, A6124501, A6124502, A6110401, A147112602, A258018801, B5131818, A5968201, A130541401, A5380304, A5260003, B5767801, A130693801, A174758001, A140158101, A174051701, B5131817, A6095201, M5389201, L5389201, A5809709, A5958402, A118189801, A5806323, A5161606, A101031001, A146202101, B103443901, A5152967, A5715233, C5618310, A5715240, A5715241, A5715259, A5961502, A5725504, A5307201, N5389201, C5389202, B5495516, A119703501, A6165901, A6165902, A5811908, A5367101, A5178019, A5178029, A195945609, A5304827, A5353829, A6089301, A6089303, A6089304, A6089306, A6141701, A5483703, A5958003, A5983601, A6049301, A5977401, A258022001, A5985601, A5975602, A6096703, A5358111, A51142115, A238763702, A5990601, A6001902, A236506901, A236506902, A236506903, A236506905, A236506906, A236506907, A236506908, A258022401, A258022403, A258022404, A258022405, A258022406, A258022412, A258022416, A258022419, A258022421, A258022424, A258022428, A5715201, A5715262, A5715264, A5715267, A6032002, A6032003, A6086801, A5985201, B5381901, A5980802, A5980803, A5216510, A5141812, A176817401, A6082101, A128549801, A128549803, A128549804, A161284802, A176528801, A5217506, A5114898, A5287805, KW1111US01, LB1323US01, LB1149US02, 834334016, 834334005, 834334042, 834334068, 834374457, 834334008, 834334011, 834334012, 834334030, 834334033, 834334034, 834334047, 834334017, 834334048, 834334058, 834334060, 834334066, 834334067, 834334015, 834334018, 834334057, 834334043, 834334056, 834334059, 083433NZM31194, 083433NZM31201, 083433NZM31221, 083433NZM31223, 083433NZM31259, 083433NZM31262, 083433NZM31270, 083433NZM31275, 083433NZM31427, 083433NZM31496, 083433NZM31572, 083433NZM33053, 083433NZM33054, 083433NZM33055, 083433NZM33056, 083433NZM33057, 083433NZM33377, 083433NZM33378, MU1012US01, MU1012US02, MU1012US03, ACI31938, ACI31939, ACI31940, ACI31941, 2651516, 2738051, 085633NZM33272A, 085633NZM33349G, 085633NZM33499G, OM1068US01, 0002649897, 0002507221X, 0002508220X, 843334004, 843334008, 843334010, 843334011, 843334012, 843334013, 843334015, 843334028, 843334219, 843374239, 843334000, 843334001, 843334006, 843334026, 843334027, 084333NZM31192, 084333NZM31217, 084333NZM31245, 084333NZM31429, 084333NZM31461, 084333NZM31483, 084333NZM31860, 084333NZM31874, 084333NZM32908, 084333NZM32909, 084333NZM32910, 084333NZM32911, 084333NZM32912, 084333NZM32913, 084333NZM33062, 084333NZM33063, 084333NZM33064, 084333NZM33065, 084333NZM33066, 084333NZM33067, 084333NZM33244, 084333NZM33261, 084333NZM33262, 084333NZM33263, 084333NZM33265, 084333NZM33266, 084333NZM33269, 084333NZM33274, 084333NZM33277, 084333NZM33278, 084333NZM33279, 084333NZM33280, 084333NZM33281, 084333NZM33282, 084333NZM33284, 084333NZM33298, SA2344XR01, SA2198XR01, SA2200XR01, SA2250XR01, SA2250XR02, SA2195XR04, SA2251XR01, SA2251XR07, SA2251XR08, SA2251XR09, SA2251XR10, SA2196XR01, SA2137XR02, SA2137XR03, SA2137XR07, SA2137XR01, SA2146XR02, SA2205XR01, SA2081XR01, SA2082XR01, SA2083XR01, SA2106XR01, SA2106XR03, SA2109XR01, SA2109XR02, SA2109XR03, SA2106XR02, SA2106XR04, SA1011XR06, SA1381XR02, SA1381XR03, 847334000, 847334001, 847334053, 847334058, 847334073, 847334075, 847334076, 084733NZM31243, 084733NZM31266, 084733NZM31271, 084733NZM31462, 084733NZM31471, 084733NZM31472, 084733NZM31586, 084733NZM31863, 084733NZM31872, 084733NZM31878, 084733NZM33498, 084733NZM40110A, 847334054, 847334061, 847334071, 847334074, 83033602003711, 83033602003712, 83033602003713, 83033602003714, 83033805200659, 83033809427599, 479261BD01, 492049BD01, 612711BD01, 537615BD01, 615070BD01, 717010US02, 717010US03, 717010US07, 717010US08, 717010US09, 717010US11, 483657US01, 226529BD01, 932030BD02, 579811BD01, 853330046, 853330239, 853330180, 853330215, 853330320, 853330321, 853330322, 853330323, 853330324, 853330333, 853330334, 853330335, 853330336, 853330337, 853330338, 853330339, 853330340, 853330341, 853330342, 853330347, 853330348, 853330349, 853330350, 853330351, 853330352, 853330353, 853330354, 853330358, 853330359, 853330360, 853330376, 853330377, 853330378, 853330379, 853330380, 853330381, 853330382, 853330383, 853330384, 853330385, 853330386, 853330387, 853330388, 853330389, 853330390, 853330391, 853330392, 853330394, 853330395, 853330396, 853330397, 853330398, 853330399, 853330403, 853330404, 853330405, 0853330200B, 853330256, 853330181, 853330201, 853330064, 853330216, 853330223, 853330166, 853330192, 853330212, 853330235, 853330248, 853330240, 853330191, 853330024, 853330025, 853330035, 853330036, 853330037, 853330038, 853330040, 853330045, 853330047, 853330048, 853330069, 853330070, 853330071, 853330073, 853330075, 853330076, 853330077, 853330097, 853330107, 853330108, 853330137, 853330138, 853330139, 853330140, 853330141, 853330142, 853330143, 853330144, 853330148, 853330149, 853330150, 853330151, 853330152, 853330153, 853330167, 853330168, 853330169, 853330170, 853330171, 853330172, 853330179, 853330182, 853330183, 853330184, 853330185, 853330186, 853330187, 853330193, 853330194, 853330195, 853330196, 853330202, 853330210, 853330217, 853330218, 853330219, 0853330222D, 853330228, 853330229, 853330234, 853330236, 853330238, 853330241, 853330249, 853330250, 853330254, 853330255, 853330262, 853330263, 853330266, 853330267, 853330269, 853330270, 853330281, 853330282, 853330283, 853330284, 853330285, 853330287, 853330288, 853330290, 853330291, 853330292, 853330293, 853330294, 853330297, 853330298, 853330299, 853330300, 853330301, 853330309, 853330310, 853330311, 853330312, 856330022, 856330047, 856330075, 856330076, 856330077, 856330078, 856330079, 856330080, 856330081, 856330082, 856330093, 856330095, 856330018, 856330010, 856330011, 856330012, 856330023, 856330005, 856330021, 856330050, 856330051, 856330052, 856330053, 856330006, 856330071, 856330069, 856330056, 856330026, 856330070, 085633NZM31191, 085633NZM31203, 085633NZM31224, 085633NZM31260, 085633NZM31265, 856330055, 856330015, 856330094, 856330096, 856330001, 856330102, 856330057, AE1189XR01, AE1336XR01, AE1145XR01, AE1148XR01, AE1165XR01, AE1241XR01, AE1223XR01, AE1223XR02, AE1154XR01, AE1201XR01, AE1221XR01, AE1223XR03, AE1223XR11, AE1224XR01, AE1237XR01, AE1149XR03, AE1243XR01, 20505RAD01, 20246RAD01, 20146RAD03, 11235RAD01, 10919RAD01

Distribution pattern

Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam

device · product 2 of 2

Achilles Express Bone Sonometer

Z-0113-2020
Recall number
Z-0113-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
241 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

Code information

System ID: ACE34924, AWE11358, ACE34606, ACE34652, ACE34651, AWE11894, AWE1196, ACE34927, ACE886H, AWE10447, AWE11047, AWE11098, AWE11304, AWE11312, AWE11317, AWE11381, AWE11285, ACH+12937, ACH+12932, ACH+12939, ACH+12935, ACH+12942, ACH+12936, ACH+12943, ACH+12938, ACH+12945, ACH+12940, ACH+12947, ACH+12952, ACH+12948, ACH+12871, ACH+12933, ACH+12872, ACH+12931, ACH+12290, ACH+12955, ACH+12975, ACH+12978, ACH+12983GA, ACH+12986, 2798401, 2815867, 2858452, 2876988, 2693419, 0002722584A, ACH10439, ACH31114, ACH10346, ACH10364, ACH10393, 828330086, 828330087,828330097, 828330098, 828330115, 828330091, 828330099, 828330119, 828330117, 83033100400411, 83033100024611, 83033000014510, 83033005000787, 83033004563599, 83033005000579, 83033005002887, 83033005003917, 83033000410110, 83033000415311, 83033004190909, 83033005000938, 83033005000978, 83033005002399, 83033009010429, 0002765007, 0002549803A, 83033000000018, 83033001234568, 83033009010046, 83033206010165, 83033209010165, 83033240415211, 83033245000577, 83033000011810, 0002830095, 0002960988, 0004225139, 0004241217, 83033820408610, 83033825000089, 83033825000098, 83033825000359, 83033825100325, 83033825101736, 83033826101736, 83033860068211, 83033200414211, 83033200012210, 83033200407710, 83033200407711, 83033200407712, 83033200413211, 83033205001468, 83033205105099, 83033205355099, 83033200012010, 83033200024711, 83033205104326, 83037200413111, 83033205002496, 83033205000068, 83033205004238, 83033605001326, 83033205102295, 83033209026036, 83033209026076, 0002540710, 0002767636, 0002767636A, 0002767636B, 0002767636C, 0002767636D, 83033005102305, 83033825000156, 83033205101507, 83033205101456, 83033205007588, 83033805004289, 83033205004228, 83033065000199, 83033205002037, 83033005105137, 83033806695010, 83033805001126, 0002790424, 83033600000008, 83033600308711, 83033605105157, IE1574LU01, A179802601, A258022402, 834334061, 834334010, 834334026, 834334028, 834334029, 834334004, 834334007, 834334006, 834334054, 834334055, 083433NZM30581, 083433NZM30585, 083433NZM30662, 83033008881210, 83033008881211, 0002501112B, 0002508220A, 0002791713, 0002818827, 0002732489, 0002739062, ACH+11056, 843334009, 084333NZM31123, 843334218, SA2155XR01, 847334059, 6073UL0164, 83033805200666, 853330027, 853330028, 853330029, 853330030, 853330031, 853330032, 853330033, 853330034, 853330057, 853330059, 853330060, 853330061, 853330062, 853330065, 853330072, 853330074, 853330080, 853330081, 853330082, 853330083, 853330084, 853330085, 856330003, 856330029, 856330002, 856330013, 856330019, 856330014, 856330016, 085633NZM10512, 085633NZM10524, 085633NZM11414, 085633NZM11693, 085633NZM12132, 085633NZM12134, 085633NZM12754, 085633NZM12755, 085633NZM12756, 856330009, 856330034, 856330007, 856330008, 856330004, 20181RAD02, 20181RAD03, 10423RAD02, 10423RAD03, 10423RAD04, 10423RAD05, 10423RAD06, 10423RAD07, 10423RAD08, 10423RAD09, 10423RAD10, 10423RAD11, 10423RAD12, 10423RAD13, 20356RAD03, 20357RAD01, 10422RAD02, 20355RAD02, 20109RAD02, 21001RAD01, 21008RAD01, 21008RAD02, 21008RAD03, 20358RAD01, 0002593515X, 0002638962, 859334009

Distribution pattern

Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam

Field note

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