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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76483

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

Open FDA event record

Event summary

Timeline bucket
January 31, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) Inc

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

3 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 3

882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

Z-1479-2017
Recall number
Z-1479-2017
Initiated
January 31, 2017
Classification
Class II
Status
Terminated
Quantity
1218 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

Code information

6000013, 6000025, 6000029, 6000036, 6000038, 6000045, 6000051, 6000065, 6000006, 6000070, 6000074, 6000072, 6000078, 6000081, 6000083, 6000084, 6000086, 6000090, 6000113, 6000127, 6000173, 6000174, 6000185, 6000182, 6000188, 6000183, 6000187, 6000186, 6000201, 6000215, 6000236, 6000234, 6000246, 6000296, 6000332, 6000334, 6000351, 6000368, 6000370, 6000380, 6000012, 6000152, 6340009, 6000011, 6000024, 6000175, 6000031, 6000253, 6000042, 6000052, 6000030, 6000002, 6000004, 6000069, 6000076, 6000142, 6000004A, 6000122, 6000016, 6000158, 6000189, 6000093, 6000005, 6000095, 6000092, 6000022, 6000035, 6000019, 6000023, 6000010, 6000111, 6000040, 6000056, 6000060, 6000057, 6000026, 6000054, 6000033, 6000028, 6000114, 6000003, 6000049, 6000059, 6000110, 6000020, 6000062, 6000058, 6000162, 6000018, 6000043, 6000064, 6000071, 6000027, 6000037, 6000085, 6000047, 6000017, 6000015, 6000063, 6000061, 6000048, 6000055, 6000091, 6000044, 6000106, 6000100, 6000067, 6000102, 6000096, 6000286, 6000103, 6000088, 6000107, 6000068, 6000041, 6000050, 6000104, 6000077, 6000066, 6000089, 6000094, 6000099, 6000130, 6000117, 6000080, 6000097, 6000087, 6000134, 6000073, 6000079, 6000053, 6000105, 6000244, 6000101, 6000116, 6000218, 6000121, 6000148, 6000108, 6000138, 6000143, 6000098, 6000150, 6000082, 6000118, 6000123, 6000120, 6000277, 6000147, 6000144, 6000128, 6000119, 6000109, 6000112, 6000208, 6000115, 6000125, 6000209, 6000288, 6000139, 6000160, 6000159, 6000140, 6000129, 6000184, 6000145, 6000146, 6000161, 6340008, 6000141, 6000131, 6000135, 6000132, 6000361, 6000151, 6000133, 6000238, 6000191, 6000155, 6000149, 6000153, 6000156, 6000163, 6000136, 6000254, 6000257, 6000177, 6000154, 6000270, 6000225, 6000170, 6000196, 6000126, 6000157, 11000021, 6000165, 6000164, 6000167, 6000190, 6000168, 6000166, 6000169, 6000172, 6000178, 6000405, 6000353, 6000214, 6000198, 6000197, 6000231, 6000180, 6000193, 6000192, 6000213, 6000176, 6340010, 6000179, 6000194, 6000171, 6000203, 6000195, 6000199, 6000204, 6000233, 6000212, 6000200, 6000181, 6000360, 6000202, 6000217, 6000412, 6000205, 6000210, 6000227, 6000272, 6000211, 6000230, 6000219, 6000220, 6000229, 6000228, 6000237, 6000235, 6000207, 6000206, 6000250, 6000222, 6000226, 6000046, 6000331, 6000223, 6000221, 6000287, 6000240, 6000224, 6000216, 6000014, 6000232, 6000239, 6000283, 6000249, 6000258, 6000245, 6340011, 6000256, 6000241, 6000278, 6000242, 6000243, 6000266, 6000285, 6000247, 6000259, 6000251, 6000263, 6000284, 6000345, 6000260, 6000265, 6000279, 6000255, 6000262, 6000269, 6000276, 6000274, 6000252, 6000271, 6000268, 6000267, 6000312, 6000261, 6000273, 6000006A, 6000264, 6000280, 6000281, 6000290, 6000311, 6000289, 6000275, 6000325, 6000310, 6000309, 6000416, 6000335, 6000356, 6000307, 6000302, 6000292, 6000291, 6000303, 6000294, 6000295, 6000282, 6000321, 6000297, 6000300, 6000320, 6000305, 6000301, 6000314, 6000298, 6000344, 6000364, 6000306, 6000308, 6000315, 11000111, 6000338, 6000318, 6000317, 6000299, 6000316, 6000293, 6000341, 6000313, 6000319, 6000330, 6000337, 6000350, 6000326, 6000357, 6000328, 6000327, 6000385, 6000324, 6000322, 6000336, 11000082, 6000329, 6000304, 6000323, 6000339, 6000343, 6000377, 6000403, 6000348, 6000346, 6000349, 6000378, 6000347, 6000367, 6000371, 6000383, 6000352, 6000366, 6000354, 6000355, 6000358, 6000359, 6000362, 6000365, 6000404, 6000363, 6000376, 6000411, 6000393, 6000381, 6000407, 6000369, 6000408, 6000420, 6000401, 6000387, 6000340, 6000422, 6000373, 6000372, 6000333, 6000379, 6000417, 6000375, 6000388, 6000384, 6000390, 6000400, 6000382, 6000399, 6000394, 6000395, 6000389, 6000386, 6000409, 6000396, 6000342, 6000424, 6000425, 6000423, 6000391, 6000392, 6000402, 6000398, 6000428, 6000406, 6000410, 6000414, 6000413, 6000427, 6000421, 6000418, 6000374, 6000426, 6000415, 6000419, 6000075, 6000032 & 6000039.

Distribution pattern

Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.

device · product 2 of 3

882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

Z-1480-2017
Recall number
Z-1480-2017
Initiated
January 31, 2017
Classification
Class II
Status
Terminated
Quantity
1218 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

Code information

4000201, 40007030003, 40007060006, 4000586, 4000327, 4000307, 4000361, 4000146, 4000159, 4000077, 4000050, 4000687, 4000325, 4000165, 4000252, 4000315, 4000191, 4000598, 4000141, 4000565, 4000135, 4000537, 4000591, 4000311, 4000626, 4000636, 4000329, 4000181, 4000644, 4000171, 4000120, 4000484A, 4000441, 4000054, 4000110, 4000653, 4000590, 4000100, 4000520, 4000323, 4000403, 4000406, 4000489, 4000277, 4000306, 4000332, 4000635, 4000270, 4000302, 4000046, 4000214, 4000615, 4000187, 4000660, 4000383, 4000633, 4000322, 4000212, 4000628, 4000034, 4000232, 4000668, 4000480, 4000430, 4000553, 4000467, 4000221, 4000127, 4000259, 4000670, 4000193, 4000222, 4000289, 4000597, 4000439, 4000542, 4000531, 4000588, 4000358, 4000330, 4000508, 4000310, 4000371, 4000501, 4000609, 4000616, 4000116, 4000452, 4000058, 4000521, 4000059, 4000064, 4000482, 4000384, 4000528, 4000177, 4000506, 4000278, 4000089, 4000139, 4000130, 4000564, 4000578, 4000674, 4000083, 4000583, 4000225, 4000267, 4000563, 4000587, 4000117, 4000053, 4000662, 4000526, 4000207, 4000118, 4000103, 4000556, 4000247, 4000326, 4000174, 4000248, 4000642, 4000696, 4000182, 4000456, 4000060, 4000522, 4000448, 4000099, 4000246, 4000175, 4000524, 4000630, 4000155, 4000367, 4000360, 4000492, 4000037, 4000230, 4000308, 4000236, 4000143, 4000285, 4000505, 4000206, 4000684, 4000164, 4000004, 4000650, 4000671, 4000473, 4000405, 4000235, 4000242, 4000680, 4000318, 4000561, 4000149, 4000073, 4000240, 4000606, 4000610, 4000304, 4000584, 4000580, 4000460, 4000263, 4000347, 4000632, 4000265, 4000368, 4000055, 4000349, 4000658, 4000351, 4000388, 4000589, 4000558, 4000106, 4000144, 4000444, 4000292, 4000098A, 4000319, 4000245, 4000295, 400054, 4000470, 4000666, 4000111, 4000148, 4000076, 4000443, 4000575, 4000654, 4000251, 4000108, 4000657, 4000659, 4000562, 4000535, 4000435, 4000357,4000677, 4000453, 4000377, 4000387, 4000446, 4000608, 40007060008, 4000036, 4000433, 4000538, 4000474, 4000414, 4000569, 4000266, 4000204, 4000119, 4000079, 4000234, 4000253, 4000192, 4000249, 4000634, 4000152, 4000380, 4000513, 4000198, 4000313, 4000340, 4000525, 4000541, 4000231, 4000424, 4000161, 4000170, 4000048, 4000239, 4000124, 4000200, 40007050005, 40007060007, 4000625, 4000264, 4000534, 4000261, 4000359, 4000220, 4000136, 4000140, 4000355, 4000087, 4000104, 4000611, 4000002, 4000040, 4000093, 4000258, 4000352, 4000291, 4000132, 4000334, 4000486, 4000271, 4000599, 4000605, 4000196, 4000363, 4000656, 4000362, 4000074, 4000577, 4000151-1, 4000238, 4000007, 4000113, 4000284, 4000260, 4000244, 4000391, 4000344, 4000695, 4000112, 4000205, 4000250, 4000052, 4000432, 4000275, 4000185, 4000646, 4000094, 4000215, 4000507, 4000090, 40000101, 4000582, 4000594, 4000128, 4000661, 4000431, 4000703001, 4000523, 4000078, 4000425, 4000062, 4000145, 4000011, 4000426, 4000440, 4000529, 4000450, 4000509, 4000241, 4000320, 40000092, 4000603, 4000496, 4000532, 4000502, 4000255, 4000593, 4000490, 4000293, 4000434, 4000619, 4000438, 4000095, 4000499, 4000623, 4000517, 4000624, 4000162, 4000402, 4000574, 4000476, 4000629, 4000649, 4000685, 4000596, 4000160, 4000546, 4000622, 4000186, 4000189, 4000445, 4000429, 4000274, 4000697, 4000673, 4000038, 4000176, 4000404, 4000114, 4000309, 4000138, 4000188, 4000369, 4000178, 4000459, 4000461, 4000468, 4000063, 4000150, 4000210, 4000217, 4000547, 4000527, 4000279, 4000208, 4000216, 4000269, 4000125, 4000254, 4000345, 4000415, 4000282, 4000449, 4000679, 4000199, 4000211, 4000331, 4000082, 4000134, 4000163, 4000373, 4000409, 4000465, 4000471, 4000545, 4000618, 4000637, 4000641, 4000153, 4000539, 4000663, 4000676, 4000477, 4000299, 4000133, 4000675, 4000314, 4000686, 4000209, 4000010, 4000621, 4000041, 4000167, 4000203, 4000407, 4000543, 4000374, 4000428, 4000157, 4000013, 4000075, 4000080, 4000086, 4000392, 4000396, 4000481, 4000689, 4000420, 4000690, 4000530, 4000639, 4000479, 4000568, 4000300, 4000572, 4000573, 4000640, 4000183, 4000142, 4000066, 4000226, 4000475, 4000519, 4000691, 4000645, 4000035, 4000219, 4000485, 4000643, 4000376, 4000416, 4000243, 4000437, 4000694, 4000551, 4340004, 4000272, 4000478, 4000296, 4000354, 4000493, 4000072, 4000237, 4000107, 4000227, 4000105, 4000698, 4000333, 4000339, 4000385, 4000109, 4000115, 4000356, 4000257, 4000173, 4000126, 4000121, 4000494, 4000398, 4000503, 4000386, 4000399, 4000179, 4000600, 4000400, 4000397, 4000194, 4000154, 4000504, 4000233, 4000256, 4000667, 4000401, 4000394, 4000585, 4000168, 4000631, 4000268, 4000382, 4000692, 4000693, 4000337, 4000595, 4000447, 4000273, 4000169, 4000442, 4000412, 4000488, 4000297, 4000228, 4000156, 4000047, 4000049, 4000096, 4000281, 4000288, 4000484, 4340005, 10422, 4000419, 4000462, 4000463, 4000464, 4000638, 4000390, 4000348, 4000613, 4000655, 4000286, 4000294, 4000395, 4000672, 4000057-OLD, 4000389, 4000290, 4000283, 4000312, 4000328, 4000375, 4000560, 4000366, 4000417, 4000051, 4000372, 4000151, 4000422, 4000195, 4000088, 4000381, 4000071, 4000003, 4000549, 4000487, 4000056, 4000006, 4000466, 4000550, 4000346, 4000683, 4000483, 4000301, 4000158, 4000223, 4000045, 4000129, 4000057, 4000557, 4000567, 4000370, 4000536, 4000029, 4000607, 4000067, 4000068, 4000032, 4000423, 4000039, 4000031, 4000620, 4000678, 4000601, 4000122, 4000647, 4000341, 4000316, 4000342, 4000408, 4000421, 4000495, 4000511, 4000664, 4000317, 4000338, 4000604, 4000682, 4000540, 4000137, 4000343, 4000030, 4000379, 4000451, 4000533, 4000602, 4000472A, 4000581, 4000469, 4000648, 4000510, 4000454, 4000335, 4000436, 4000353, 4000418, 4000491, 4000571, 4000197, 4000555, 4000518, 4000544, 4000500, 4000592, 4000617, 4000012, 4000213, 4000413, 4000699, 4000218, 4000123, 4000287, 4000070, 4000166, 4000202, 4000102, 4000276, 4000091, 4000301-1, 4000455, 4000033, 4000364, 4000008, 4000497, 4000498, 4000681, 4000009, 4000184, 4000554, 4000516, 4000303, 4000576, 4000190, 4000305, 4000411, 4000669, 4000614, 4000324, 4000612, 4000566, 4000627, 4000552, 4000280, 4000378, 4000336, 4000559, 4000229, 4000262, 4000298, 4000043, 400000275, 4000044, 4000065, 4000061, 4000180, 4000224, 4000321, 4000081, 4000410, 4000651, 4000652, 4000665, 4000688 & 5000916,

Distribution pattern

Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.

device · product 3 of 3

882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

Z-1481-2017
Recall number
Z-1481-2017
Initiated
January 31, 2017
Classification
Class II
Status
Terminated
Quantity
1218 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

Code information

11000100, 11000019, 11000034, 11000020, 11000112, 11000086, 11000045, 11000092, 11000037, 11000038, 11000106, 11000059, 11000064, 11000039, 11000087, 11000004, 11000058, 11000030, 11340005, 11000113, 11000117, 11000011, 11000118, 11000074, 11000075, 11000036, 11000104, 11000103, 11000071, 11340002, 11000089, 11000012, 11000041, 11000042, 11000043, 11000049, 11000014, 11000099, 11000022, 11000031, 11000005, 11000028, 11000073, 11000040, 11000077, 11000008, 11000048, 11000093, 11000096, 11000097, 11000069, 11000079, 11000080, 11000024, 11000076, 11000085, 11000108, 11000109, 11000115, 11000056, 11000029, 11340003, 11000044, 11000107, 11000090, 11000017, 11000110, 11000009, 11000035, 11000081, 11000062, 11000013, 11000015, 11000063, 11000083, 11000091, 11000098, 11000054, 11340004, 11000102, 11000061, 11000095, 11000023, 11000094, 11000060, 11000055, 11000070, 11000084, 11000088, 11000068, 11000052, 11000057, 11000050, 11000067, 11000007, 11000010, 11000027, 11000032, 11340001, 11000026, 11000114, 11000078, 11000051, 11000046, 11000003, 11000018, 11000066, 11000047, 11000101, 11000065, 11000072, 11000116, 11000016, 11000105, 11000025, 11000006, 11000033,

Distribution pattern

Worldwide distribution. US nationwide, ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CAYMEN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GABON, GERMANY, GREAT BRITAIN, GREECE, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, & VIETNAM.

Field note

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