Canon Medical System, USA, INC. device recall (Cls II)

Alphenix INFX-8000C, interventional fluoroscopic x-ray system — Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed — Status: Ongoing