| Class 2 Device Recall Brightview XCT | |
Date Initiated by Firm | January 31, 2017 |
Date Posted | March 16, 2017 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-1479-2017 |
Recall Event ID |
76483 |
510(K)Number | K062298 K080927 |
Product Classification |
diagnostic scanner - Product Code KPS
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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). |
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. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Ms. Holly Wright Lee 440-483-2015 |
Manufacturer 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 |
FDA Determined Cause 2 | Software design |
Action | Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPS 510(K)s with Product Code = KPS
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