Device product
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Z-2736-2016
Product summary
- Event
- Event 74894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 424 units
- Official record key
device-enforcement:Z-2736-2016
Official wording
Reason: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
Code information: 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
Distribution pattern: Worldwide distribution. US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Derived failure modes
-
Device software or design
software defect