🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 12, 2014 Philips Medical Systems (Cleveland) Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Medical Systems (Cleveland) Inc
Reason for Recall:
Unintended detector and gantry movement due to software issues.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1011-2015

Related Recalls

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

Aug 5, 2025 Other Medical Devices Nationwide View Details →