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.
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. Quantity: 56 US; 46 OUS Lot/code info: All serial numbers are affected. No UDI-DI available for this product.
Official record: FDA (Device enforcement) ↗
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