Canon Medical System, USA recalled 332 units of the Alphenix INFX-8000V X-ray system on December 19, 2025. Loose fixing screws may hinder ceiling movement and cause sensor errors. Healthcare providers must stop using the device immediately and follow manufacturer's instructions.
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
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Canon Medical System, USA, INC. or your healthcare provider for instructions. Notification method: Letter
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The recall affects the Alphenix INFX-8000V interventional fluoroscopic x-ray system. The affected models include serial numbers such as B2A1522117, E0514103, and A2A2152263. The devices were distributed worldwide, including US and Dominican Republic.
Loose fixing screws in the ceiling movement gear can prevent lateral movement of the device. This condition may produce abnormal noises and trigger sensor errors, increasing the risk of malfunction during medical procedures.
No specific incidents or injuries have been reported related to this recall. However, the potential for operational failure poses a serious risk in medical settings.
Healthcare providers should stop using the Alphenix INFX-8000V immediately. Contact Canon Medical System, USA, for further instructions and potential return processes.
For more details, contact Canon Medical System at their official website or through their customer service line.
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