Canon Medical Systems USA has issued a Class II recall for certain Alphenix INFX-8000V interventional fluoroscopic X-ray systems due to a mechanical issue that may affect device operation.

The recall, initiated on Dec. 19, 2025, involves 332 units distributed in the U.S. and the Dominican Republic.

The Tustin, California-based company identified a defect in the ceiling-suspended arm of the X-ray system. According to the company’s urgent field correction notice, the screws that secure the ceiling movement gear may loosen over time. This can result in restricted lateral movement, abnormal noises from the suspension system, or the display of sensor errors.
The FDA classified the recall under event ID 97970 and noted that the cause stems from process design issues. Affected units were manufactured under 510(k) clearance number K233107 and span dozens of serial numbers, which have been listed in full by the FDA.

In its letter to customers, Canon advised facilities to immediately stop using any system that exhibits abnormal sounds or error messages before corrective measures are implemented. “Should the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the device and call your local Canon Service Team,” the notice read.

Canon also urged that the notification be shared with all users, including clinical engineering and biomedical departments. Users with questions were directed to contact the company’s InTouch team or their local service representative.

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