Device Recall BrightView XCT BrightView X

  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA