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 Alphenix INFX-8000V is an interventional fluoroscopic x-ray system used in medical procedures to visualize internal structures. It is commonly used in hospitals for diagnostics and interventions.
The potential for loose fixing screws can lead to a loss of control over the device's ceiling movement, which is crucial for accurate imaging during procedures. This defect poses risks of operational failure and sensor errors.
This recall is not part of a broader industry pattern.
The recall poses an immediate safety concern for healthcare providers. It requires urgent action to prevent potential operational failures during medical procedures.
Serial numbers can typically be found on the device's back panel or within the user manual.
Expect processing for refunds or replacements to take approximately 4-8 weeks.
Keep records of your device's serial number, any correspondence with the manufacturer, and notes of any issues experienced.
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.
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