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FDAFDA · Food and drugs·Recall number Z-1982-2014

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.

Published July 9, 2014 · Recall initiated: June 23, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Flat Panel Display (FPD) failed to remain securely locked in the deployed position.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips Medical Systems (Cleveland) Inc
Distributor
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.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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