BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling BrightView, BrightView X, and BrightView XCT imaging devices due to software issues that can cause unintended movement of the detector and gantry components. A total of 1,064 units have been distributed worldwide, including throughout the United States and internationally to countries including Canada, Australia, France, Germany, Japan, China, and many others.
The recall affects specific serial numbers for each model: BrightView model 882478, BrightView X model 882480, and BrightView XCT models 882482 and 882454. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Unintended detector and gantry movement due to software issues.
Reason for recall: Unintended detector and gantry movement due to software issues. 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, Philippin Quantity: 1064 units Lot/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, 40000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.