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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips Medical Systems (Cleveland) Inc: 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

Agency Publication Date: March 16, 2017
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Affected Products

Product: 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).

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.

Product: 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).

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,

Product: 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).

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,

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76483
Status: Resolved
Manufacturer: Philips Medical Systems (Cleveland) Inc
Manufactured In: United States
Units Affected: 3 products (1218 total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.