Medical Device Recall: BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
Philips North America · December 15, 2023
Reason for Recall
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Distribution
Domestic distribution nationwide. International distribution worldwide.
States Affected
NATIONWIDE
Quantity Affected
56 US; 46 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0930-2024
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.