BEUDAMED
    FDA Enforcement Class II Terminated

    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

    Recall: Z-1011-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1011-2015
    Event ID
    69792
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    November 12, 2014
    Classification Date
    January 26, 2015
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

    Reason

    Unintended detector and gantry movement due to software issues.

    Code Info

    BrightView Model Number 882478; Affected Serial Numbers include: 11000003,11000004,11000005,11000006,11000008,11000009,11000011, 11000012,11000013,11000014,11000015,11000016,11000017,11000018, 11000019,11000020,11000023,11000024,11000025,11000026,11000027, 11000029,11000030,11000031,11000032,11000033,11000034,11000036, 11000037,11000038,11000039,11000040,11000041,11000042,11000043, 11000045,11000046,11000047,11000048,11000049,11000051,11000052, 11000054,11000055,11000056,11000057,11000058,11000059,11000060, 11000061,11000062,11000063,11000064,11000065,11000066,11000068, 11000069,11000071,11000072,11000074,11000075,11000076,11000077, 11000078,11000083,11000085,11000086,11000087,11000089,11000090, 11000091,11000092,11000093,11000094,11000095,11000096,11000097, 11000098,11000099,11000100,11000101,11000102,11000103,11000104, 11000105,11000106,11000107,11000108,11000110,11000111,11000112, 11000113,11000115,11000116,11000117,11000118,11340001,11340002, 11340004, and 11340005. BrightViewX Model Number 882480; Affected Serial Numbers include: 10422,400054,4000002,4000003,4000004,4000006,4000008, 4000009,4000010,4000011,4000013,4000029,4000030,4000031,4000032, 4000033,4000035,4000036,4000037,4000038,4000039,4000040,4000041, 4000043,4000044,4000046,4000047,4000048,4000051,4000053,4000056, 4000058,4000059,4000060,4000061,4000063,4000064,4000065,4000066, 4000067,4000068,4000070,4000071,4000072,4000073,4000074,4000075, 4000076,4000077,4000078,4000079,4000080,4000081,4000083,4000086, 4000087,4000088,4000089,4000090,4000093,4000094,4000095,4000096, 4000099,4000100,4000102,4000103,4000104,4000105,4000106,4000107, 4000108,4000109,4000111,4000112,4000113,4000114,4000115,4000116, 4000117,4000118,4000120,4000121,4000122,4000123,4000124,4000125, 4000126,4000127,4000128,4000129,4000130,4000132,4000133,4000135, 4000137,4000138,4000139,4000140,4000141,4000142,4000143,4000144, 4000146,4000148,4000149,4000150,4000151,4000152,4000153,4000154, 4000155,4000156,4000157,4000158,4000159,4000160,4000161,4000164, 4000165,4000166,4000167,4000168,4000169,4000170,4000171,4000173, 4000174,4000175,4000176,4000177,4000179,4000180,4000181,4000182, 4000183,4000184,4000185,4000187,4000188,4000189,4000190,4000191, 4000193,4000194,4000195,4000196,4000197,4000198,4000199,4000200, 4000201,4000202,4000204,4000205,4000206,4000207,4000208,4000209, 4000210,4000212,4000214,4000216,4000217,4000218,4000219,4000220, 4000222,4000223,4000224,4000225,4000226,4000227,4000228,4000229, 4000230,4000231,4000232,4000233,4000235,4000236,4000237,4000238, 4000239,4000240,4000241,4000242,4000243,4000244,4000245,4000246, 4000247,4000248,4000249,4000250,4000251,4000252,4000253,4000254, 4000255,4000256,4000257,4000258,4000259,4000260,4000261,4000262, 4000263,4000264,4000265,4000266,4000269,4000270,4000271,4000272, 4000274,4000276,4000277,4000278,4000279,4000280,4000281,4000282, 4000283,4000284,4000285,4000287,4000288,4000289,4000290,4000291, 4000292,4000293,4000295,4000296,4000297,4000298,4000299,4000300, 4000301,4000302,4000303,4000304,4000305,4000306,4000307,4000308, 4000309,4000310,4000311,4000312,4000313,4000314,4000316,4000317, 4000318,4000319,4000320,4000321,4000322,4000323,4000324,4000325, 4000326,4000327,4000328,4000329,4000330,4000331,4000333,4000334, 4000336,4000338,4000339,4000341,4000342,4000344,4000345,4000346, 4000347,4000348,4000352,4000353,4000354,4000355,4000356,4000357, 4000358,4000360,4000361,4000362,4000363,4000364,4000366,4000367, 4000368,4000369,4000370,4000371,4000372,4000374,4000375,4000376, 4000377,4000378,4000379,4000380,4000381,4000382,4000383,4000384, 4000385,4000386,4000387,4000388,4000389,4000390,4000392,4000394, 4000394,4000396,4000397,4000398,4000399,4000400,4000401,4000402, 4000403,4000405,4000406,4000407,4000408,4000410,4000411,4000412, 4000414,4000415,4000416,4000417,4000418,4000419,4000420,4000421, 4000422,4000423,4000424,4000425,4000426,4000428,4000429,4000430, 4000431,4000432,4000433,4000434,4000435,4000437,4000438,4000439, 4000440,4000441,4000442,4000443,4000444,4000445,4000446,4000448, 4000449,4000450,4000451,4000452,4000453,4000454,4000455,4000456, 4000459,4000460,4000461,4000462,4000463,4000464,4000466,4000467, 4000468,4000469,4000470,4000473,4000474,4000475,4000476,4000477, 4000478,4000479,4000480,4000481,4000482,4000483,4000485,4000486, 4000487,4000488,4000489,4000490,4000491,4000492,4000494,4000495, 4000496,4000498,4000499,4000501,4000502,4000503,4000504,4000505, 4000506,4000507,4000508,4000509,4000510,4000511,4000513,4000516, 4000518,4000519,4000520,4000521,4000522,4000523,4000524,4000525, 4000526,4000527,4000528,4000529,4000530,4000531,4000532,4000533, 4000534,4000535,4000536,4000537,4000538,4000539,4000540,4000541, 4000542,4000543,4000544,4000546,4000547,4000549,4000550,4000552, 4000553,4000554,4000555,4000556,4000557,4000558,4000559,4000560, 4000561,4000562,4000563,4000564,4000565,4000566,4000567,4000568, 4000569,4000571,4000572,4000573,4000574,4000575,4000576,4000577, 4000578,4000580,4000581,4000582,4000583,4000584,4000585,4000586, 4000587,4000588,4000589,4000590,4000591,4000592,4000593,4000594, 4000596,4000597,4000598,4000600,4000601,4000602,4000603,4000604, 4000606,4000607,4000608,4000610,4000611,4000612,4000614,4000615, 4000619,4000620,4000621,4000623,4000624,4000625,4000626,4000627, 4000628,4000629,4000630,4000631,4000632,4000633,4000634,4000635, 4000636,4000638,4000639,4000640,4000642,4000643,4000644,4000645, 4000646,4000647,4000649,4000650,4000654,4000655,4000656,4000657, 4000658,4000659,4000660,4000661,4000662,4000663,4000664,4000666, 4000667,4000668,4000669,4000670,4000671,4000672,4000673,4000674, 4000676,4000677,4000678,4000679,4000680,4000681,4000682,4000683, 4000684,4000685,4000686,4000689,4000690, 4000692, 4000693, 4000694, 4340004, 40000092, 40000101, 4000703001, 40007050005, 40007060007, 40007060008, 4000098A, 4000472A, 4000484A, and One Unknown. BrightView XCT Model Numbers 882482 and 882454; Affected Serial Numbers include: 6000002,6000003,6000004,6000005,6000006,6000010, 6000011,6000012,6000013,6000015,6000016,6000017,6000019,6000020, 6000022,6000023,6000026,6000027,6000028,6000030,6000031,6000032, 6000033,6000036,6000037,6000038,6000039,6000040,6000041,6000042, 6000043,6000044,6000045,6000047,6000048,6000049,6000050,6000051, 6000052,6000053,6000054,6000055,6000056,6000058,6000060,6000061, 6000062,6000063,6000064,6000065,6000066,6000067,6000068,6000069, 6000070,6000071,6000073,6000075,6000076,6000077,6000078,6000079, 6000080,6000081,6000082,6000083,6000084,6000085,6000086,6000087, 6000088,6000089,6000090,6000091,6000092,6000093,6000094,6000095, 6000098,6000099,6000100,6000101,6000102,6000103,6000104,6000105, 6000107,6000108,6000109,6000110,6000111,6000112,6000113,6000114, 6000115,6000116,6000117,6000118,6000119,6000120,6000121,6000122, 6000123,6000125,6000126,6000127,6000128,6000129,6000130,6000131, 6000132,6000133,6000134,6000136,6000138,6000139,6000140,6000141, 6000142,6000143,6000144,6000145,6000146,6000147,6000148,6000149, 6000150,6000151,6000152,6000153,6000154,6000156,6000157,6000158, 6000159,6000160,6000161,6000162,6000163,6000164,6000165,6000166, 6000167,6000168,6000169,6000171,6000172,6000173,6000174,6000175, 6000176,6000177,6000178,6000180,6000181,6000182,6000183,6000184, 6000185,6000186,6000187,6000188,6000189,6000190,6000191,6000192, 6000193,6000194,6000195,6000196,6000197,6000198,6000199,6000200, 6000201,6000202,6000203,6000204,6000205,6000206,6000208,6000209, 6000210,6000211,6000212,6000213,6000214,6000215,6000216,6000218, 6000219,6000220,6000221,6000222,6000223,6000224,6000225,6000226, 6000227,6000228,6000229,6000230,6000231,6000232,6000233,6000234, 6000235,6000236,6000237,6000238,6000239,6000240,6000241,6000242, 6000243,6000244,6000245,6000246,6000247,6000249,6000250,6000251, 6000252,6000253,6000254,6000256,6000257,6000258,6000260,6000262, 6000263,6000264,6000265,6000266,6000267,6000268,6000269,6000270, 6000271,6000273,6000274,6000275,6000276,6000277,6000278,6000279, 6000280,6000281,6000282,6000283,6000284,6000285,6000286,6000287, 6000288,6000290,6000291,6000292,6000293,6000294,6000295,6000296, 6000297,6000298,6000299,6000300,6000301,6000302,6000303,6000305, 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, 6000339,6000340,6000341,6000343,6000344,6000345,6000346,6000348, 6000349,6000350,6000351,6000352,6000353,6000354,6000355,6000356, 6000358,6000359,6000360,6000361,6000362,6000364,6000365,6000366, 6000367,6000368,6000369,6000370,6000371,6000372,6000373,6000374, 6000375,6000376,6000377,6000378,6000379,6000380,6000381,6000382, 6000383,6000384,6000385,6000386,6000387,6000389,6000390,6000391, 6000392,6000393,6000394,6000395,6000396,6000398,6000399,6000400, 6000401,6000402,6000403,6000404,6000407,6000408,6000409,6000410, 6000411,6000413,6000414,6000415,6000416, 6000417, 6000418, 6340008, 6340009, 6340010,11000021, and 6000004A.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United Kingdom, and Viet Nam.

    Quantity

    1064 units