882482: BrightView XCT 882454 BrightView X upgrade to recall
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies.…
Why was 882482: BrightView XCT 882454 BrightView X upgrade to recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies.…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 1218 total
- Distribution
- 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.
- Recall date
- March 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)