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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69792

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 12, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1011-2015
Recall number
Z-1011-2015
Initiated
November 12, 2014
Classification
Class II
Status
Terminated
Quantity
1064 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unintended detector and gantry movement due to software issues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unintended detector and gantry movement due to software issues.

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.

Distribution pattern

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.