Medical Device Recall: BrightView, Gamma Camera System, Product Code 882480.
Philips North America · November 30, 2023
Reason for Recall
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.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
States Affected
NATIONWIDE
Quantity Affected
359 US; 328 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0677-2024
Status: ongoing
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