GE—Replacement Power Supply Used with LightSpeed CT and Discovery PET/CT Scanners: May Become Loose on Gantry during Operation
July 29, 2015 | Risk Management News
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In a July 17, 2015, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, GE states that the service procedure used to replace the power supplies on the rotating gantry of the scanners below may specify the wrong torque for the mounting hardware. As a result, the 3 mounting bolts securing the power supply may have been over-torqued, potentially causing the power supply to become loose on the gantry. If the power supply is expelled from the system during operation, serious injury could occur. GE states that it has received no reports of incidents or injuries associated with this problem. The manufacturer has not confirmed the information provided in the source material.