Device 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).
Z-1479-2017
Product summary
- Event
- Event 76483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1218 total
- Official record key
device-enforcement:Z-1479-2017
Official wording
Reason: 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.
Derived failure modes
-
Unknown
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