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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView, BrightView X, and BrightView XCT

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  Class 2 Device Recall BrightView, BrightView X, and BrightView XCT see related information
Date Initiated by Firm November 12, 2014
Date Posted January 26, 2015
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-1011-2015
Recall Event ID 69792
510(K)Number K080927  
Product Classification System, tomography, computed, emission - Product Code KPS
Product BrightView model number: 882478
BrightView X model number: 882480
BrightView XCT model number: 882482 and 882454

Medical Device for imaging
Code Information 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.  
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Daniel R. Brown
440-483-2119
Manufacturer Reason
for Recall		 Unintended detector and gantry movement due to software issues.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare sent an Urgent - Field Safety Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is advising the customers/users to retain a copy of this Field Safety BY CUSTOMER I USER Notice with the equipment Instruction for Use, until further notice. Problem #1: Philips is advising the customer/user to perform the following workaround prior to the implementation of the field safety correction, to avoid contact between the detector and the head holder as describe above in Problem #1: ONLY if the system is positioned in a Relative-90 configuration with one of the detectors below the pallet level and the table in in the patient load position: Follow the sequence of operations prior to performing a study utilizing the head holder: - Deploy or store the x-ray panel if necessary; - Run the patient load PPM; - Install the head holder; and - Position the patient on the table and proceed with the study In addition, take the following preventative actions: " Monitor the patient during any and all system motions. " Know locations of the multiple E-Stop button(s) to halt all system motion. (Emergency Stop: where the system immediately stops all detector and gantry motions by disconnecting power to the motors that control system motion) Customers with questions were instructed to contact the Customer Care Solutions Certer at 1-800-722-9377. For questions regarding this recall call 440-483-2119.
Quantity in Commerce 1064 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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