Device product
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
Z-1982-2014
Product summary
- Event
- Event 68644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 407
- Official record key
device-enforcement:Z-1982-2014
Official wording
Reason: Flat Panel Display (FPD) failed to remain securely locked in the deployed position.
Code information: BrightView XCT: product code 882482 BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454 All Codes: 6000002,6000004,6000005,6000006,6000010,6000011,6000012,6000013,6000015,6000016, 6000017,6000018,6000019, 600020, 6000021, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027,6000028,6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038,6000040,6000041, 6000042, 6000043, 6000044, 6000045, 6000046, 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, 6000094,6000095,6000096,6000097,6000098,6000099,6000100,6000101, 6000102, 6000103, 6000104,6000105,6000106,6000107,6000108,6000109,6000110,6000111, 6000112, 6000113, 6000114,6000115,6000116,6000117,6000118,6000119,6000120,6000121, 6000122, 6000123, 6000125,6000127,6000128,6000130,6000131,6000132,6000133,6000134, 6000136, 6000139, 6000141,6000142,6000143,6000144,6000146,6000147,6000148,6000149,6000150,6000151, 6000152,6000154,6000155,6000156,6000157,6000158,6000159,6000160,6000161,6000162, 6000163,6000164,6000165,6000166,6000167,6000168,6000169,6000170,6000171,6000172, 6000173,6000174,6000175,6000176,6000177,6000178,6000179,6000180,6000181,6000182, 6000183,6000184,6000185,6000186,6000187,6000188,6000189,6000190,6000191,6000192, 6000193,6000194,6000195,6000197,6000198,6000199,6000200,6000201,6000202,6000203, 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, 6000234,6000235,6000236,6000237,6000238,6000239,6000240,6000241,6000242,6000243, 6000244,6000245,6000246,6000247,6000248,6000249,6000250,6000251,6000252,6000253, 6000254,6000255,6000257,6000258,6000259,6000260,6000261,6000262,6000263,6000264, 6000265,6000266,6000267,6000268,6000269,6000270,6000271,6000272,6000273,6000274, 6000275,6000276,6000277,6000278,6000279,6000280,6000281,6000282,6000283,6000284, 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, 6000325,6000326,6000327,6000329,6000330,6000331,6000332,6000333,6000334,6000335, 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
Distribution pattern: Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
Derived failure modes
-
Unknown
Flat Panel Display (FPD) failed to remain securely locked in the deployed position.