Class II

Medical Device Recall: BrightView X, Gamma Camera, Product Code 882478

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

59 US; 59 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0678-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.