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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: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause

Agency Publication Date: February 26, 2016
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Affected Products

Product: BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

Model # 882480; Serial #'s: 4000002, 4000002.75, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061, 4000062, 4000064, 4000065, 4000066, 4000068, 4000070, 4000071, 4000072, 4000073, 4000074, 4000075, 4000076, 4000077, 4000078, 4000079, 4000080, 4000081, 4000082, 4000083, 4000086, 4000087, 4000088, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000096, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120, 4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000134, 4000135, 4000136, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000163, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000196, 4000197, 4000198, 4000199, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000211, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 4000262, 4000263, 4000264, 4000265, 4000266, 4000267, 4000268, 4000269, 4000270, 4000271, 4000272, 4000273, 4000274, 4000275, 4000276, 4000277, 4000278, 4000279, 4000280, 4000281, 4000282, 4000283, 4000284, 4000285, 4000286, 4000287, 4000288, 4000289, 4000290, 4000291, 4000292, 4000293, 4000294, 4000295, 4000296, 4000297, 4000298, 4000299, 4000300, 4000301, 4000302, 4000303, 4000304, 4000305, 4000306, 4000307, 4000308, 4000309, 4000310, 4000311, 4000312, 4000313, 4000314, 4000315, 4000316, 4000317, 4000318, 4000319, 4000320, 4000321, 4000322, 4000323, 4000324, 4000325, 4000326, 4000327, 4000328, 4000329, 4000330, 4000331, 4000332, 4000333, 4000334, 4000335, 4000336, 4000337, 4000338, 4000339, 4000340, 4000341, 4000342, 4000343, 4000344, 4000345, 4000346, 4000347, 4000348, 4000349, 4000351, 4000352, 4000353, 4000354, 4000355, 4000356, 4000357, 4000358, 4000359, 4000360, 4000361, 4000362, 4000363, 4000364, 4000366, 4000367, 4000368, 4000369, 4000370, 4000371, 4000372, 4000373, 4000374, 4000375, 4000376, 4000377, 4000378, 4000379, 4000380, 4000381, 4000382, 4000383, 4000384, 4000385, 4000386, 4000387, 4000388, 4000389, 4000390, 4000391, 4000392, 4000394, 4000395, 4000396, 4000397, 4000398, 4000399, 4000400, 4000401, 4000402, 4000403, 4000404, 4000405, 4000406, 4000407, 4000408, 4000409, 4000410, 4000411, 4000412, 4000414, 4000415, 4000416, 4000417, 4000418, 4000419, 4000420, 4000421, 4000422, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000431, 4000432, 4000433, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000465, 4000466, 4000467, 4000468, 4000469, 4000470, 4000471, 4000473, 4000474, 4000475, 4000476, 4000477, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000484, 4000485, 4000486, 4000487, 4000488, 4000489, 4000490, 4000491, 4000492, 4000493, 4000494, 4000495, 4000496, 4000497, 4000498, 4000499, 4000500, 4000501, 4000502, 4000503, 4000504, 4000505, 4000506, 4000507, 4000510, 4000511, 4000513, 4000516, 4000517, 4000518, 4000519, 4000520, 4000521, 4000522, 4000523, 4000524, 4000525, 4000526, 4000527, 4000528, 4000529, 4000530, 4000531, 4000532, 4000533, 4000534, 4000535, 4000536, 4000537, 4000538, 4000539, 4000540, 4000541, 4000542, 4000543, 4000544, 4000545, 4000546, 4000547, 4000549, 4000550, 4000551, 4000552, 4000553, 4000554, 4000555, 4000556, 4000557, 4000558, 4000559, 4000560, 4000561, 4000562, 4000563, 4000564, 4000565, 4000566, 4000567, 4000568, 4000569, 4000571, 4000572, 4000573, 4000574, 4000575, 4000576, 4000577, 4000578, 4000580, 4000581, 4000582, 4000583, 4000584, 4000585, 4000586, 4000587, 4000588, 4000589, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000599, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000608, 4000609, 4000610, 4000611, 4000612, 4000613, 4000614, 4000615, 4000616, 4000617, 4000618, 4000619, 4000620, 4000621, 4000622, 4000623, 4000624, 4000625, 4000626, 4000627, 4000628, 4000629, 4000630, 4000631, 4000632, 4000633, 4000634, 4000635, 4000636, 4000637, 4000638, 4000639, 4000640, 4000641, 4000642, 4000643, 4000644, 4000645, 4000646, 4000647, 4000648, 4000649, 4000650, 4000651, 4000652, 4000653, 4000654, 4000655, 4000656, 4000657, 4000658, 4000659, 4000660, 4000661, 4000662, 4000663, 4000664, 4000665, 4000666, 4000667, 4000668, 4000669, 4000670, 4000671, 4000672, 4000673, 4000674, 4000675, 4000676, 4000677, 4000678, 4000679, 4000680, 4000681, 4000682, 4000683, 4000684, 4000685, 4000686, 4000687, 4000688, 4000689, 4000690, 4000691, 4000692, 4000693, 4000694, 4000695, 4000696, 4000697, 4000698, 4000699, 4340004, 4340005, 40000092, 40000101, 4000703001, 40007030003, 40007050005, 40007060008, 4000057-OLD, 4000098A, 4000151-1, 4000301-1, 4000472A, 4000484A, 10422, 400054, 4000029, 4000063, 4000067, 4000150, 4000195, 4000201, 4000210, 4000217, 4000252, 4000508, 4000509, 40007060006, 40007060007, 4000012, 4000213 & 4000413.

Product: BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

Model #: 882478; Serial #'s: 11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013, 11000014, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000027, 11000028, 11000029, 11000031, 11000032, 11000033, 11000034, 11000035, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000044, 11000045, 11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000079, 11000080, 11000081, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, 11000107, 11000108, 11000109, 11000110, 11000112, 11000113, 11000114, 11000115, 11000116, 11000117, 11000118, 11340001, 11340002, 11340003, 11340004, 11340005 & 11000015.

Product: BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

Model #: 882482; Serial #'s: 6000016, 6000111, 6000114, 6000122, 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000057, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000068, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000075, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000112, 6000113, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000135, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000207, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6000241, 6000242, 6000244, 6000245, 6000246, 6000247, 6000249, 6000250, 6000251, 6000252, 6000253, 6000254, 6000255, 6000256, 6000257, 6000258, 6000259, 6000260, 6000261, 6000262, 6000263, 6000264, 6000265, 6000266, 6000267, 6000268, 6000269, 6000270, 6000271, 6000272, 6000273, 6000274, 6000275, 6000276, 6000277, 6000278, 6000279, 6000280, 6000281, 6000283, 6000284, 6000285, 6000286, 6000287, 6000288, 6000289, 6000290, 6000291, 6000292, 6000293, 6000294, 6000295, 6000296, 6000297, 6000298, 6000299, 6000300, 6000301, 6000302, 6000303, 6000304, 6000305, 6000306, 6000307, 6000308, 6000309, 6000310, 6000311, 6000312, 6000313, 6000314, 6000315, 6000316, 6000317, 6000318, 6000319, 6000320, 6000321, 6000322, 6000323, 6000324, 6000325, 6000326, 6000327, 6000328, 6000329, 6000330, 6000331, 6000332, 6000333, 6000334, 6000335, 6000336, 6000337, 6000338, 6000339, 6000340, 6000341, 6000342, 6000343, 6000344, 6000345, 6000346, 6000347, 6000348, 6000349, 6000350, 6000351, 6000352, 6000353, 6000354, 6000355, 6000356, 6000357, 6000358, 6000359, 6000360, 6000361, 6000362, 6000363, 6000364, 6000365, 6000366, 6000367, 6000368, 6000369, 6000370, 6000371, 6000372, 6000373, 6000374, 6000375, 6000376, 6000377, 6000378, 6000379, 6000380, 6000381, 6000382, 6000383, 6000384, 6000385, 6000386, 6000387, 6000388, 6000389, 6000390, 6000391, 6000392, 6000393, 6000394, 6000395, 6000396, 6000398, 6000399, 6000400, 6000401, 6000402, 6000403, 6000404, 6000405, 6000406, 6000407, 6000408, 6000409, 6000410, 6000411, 6000412, 6000413, 6000414, 6000415, 6000416, 6000417, 6000418, 6000419, 6000420, 6000421, 6000422, 6000423, 6000424, 6000425, 6000426, 6000427, 6000428, 6340008, 6340009, 6340010, 6340011, 6000004A, 6000014, 6000039, 6000046, 6000082, 6000163, 6000243, 6000282 & 6000006A. XCT Upgrade Model #: 882454; Serial #'s: 11000021, 11000082 & 11000111.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73010
Status: Resolved
Manufacturer: Philips Medical Systems (Cleveland) Inc
Manufactured In: United States
Units Affected: 3 products (677 units; 117 units; 427 units)

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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.