Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.
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-8000C is an advanced interventional fluoroscopic x-ray system designed for medical imaging. Healthcare facilities utilize this system for various diagnostic and surgical procedures.
The potential loosening of screws in the ceiling movement gear can prevent proper operation of the x-ray system, leading to operational failures and possible safety hazards during medical procedures.
This recall is not part of a broader industry pattern.
Healthcare providers must cease using the affected x-ray systems, which can disrupt medical services and patient care.
Serial numbers can typically be found on the device's information label or manufacturer's plate.
Expect a response for refund processing or instructions within 4-6 weeks.
Keep a record of all communications regarding the recall, including emails, letters, and any instructions received.
The recall involves the Canon Alphenix INFX-8000C interventional fluoroscopic x-ray system. The affected serial numbers include W1C0632284, W4A1282279, and others. These units were distributed worldwide, including the U.S. and the Dominican Republic.
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