Canon Medical System, USA recalled 98 units of its Alphenix INFX-8000F X-ray system on December 19, 2025. Loose fixing screws in the ceiling movement gear may cause malfunction and abnormal noise. Healthcare providers should stop using the system immediately and follow recall 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-8000F is an advanced interventional fluoroscopic x-ray system used in medical settings for imaging and guiding procedures. Healthcare providers rely on its functionality for accurate diagnostics and patient care.
The risk arises from loose screws in the ceiling movement gear of the x-ray system. This defect can hinder movement and generate noise, affecting the system's performance and potentially compromising patient safety.
This recall is not part of a broader industry pattern.
The recall necessitates immediate cessation of use by healthcare providers, potentially affecting patient care and leading to operational disruptions in facilities.
The model numbers can typically be found on the device's identification plate or in the user manual provided by the manufacturer.
Expect a timeline of 4-8 weeks for refund processing once your request is submitted.
Keep records of your purchase, correspondence with the manufacturer, and any documentation from the recall process.
The recall affects 98 units of the Alphenix INFX-8000F interventional fluoroscopic x-ray system. The devices were distributed worldwide, including the US and the Dominican Republic.
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