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Philips North America recalls BrightView X, Gamma Camera, Product Code 882478
Recalled January 17, 2024 · FDA recall Z-0678-2024 · Philips North America
Hazard
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion. · FDA Class II
Units
59 US; 59 OUS
Sold at
Domestic distribution nationwide. Foreign distribution worldwide.
Description
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Product
BrightView X, Gamma Camera, Product Code 882478
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →