Canon Medical System, USA recalled 3 interventional fluoroscopic x-ray systems on December 19, 2025. The recall follows reports that fixing screws in the ceiling movement gear may become loose, causing operational failures. Users should stop using the device immediately and follow provided 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-8000H is an interventional fluoroscopic x-ray system used in medical settings for imaging during procedures. Healthcare providers rely on it for accurate diagnostics and treatment planning.
The potential loosening of screws in the ceiling movement gear could impair the device's functionality, leading to operational failures during critical medical procedures.
This recall is not part of a broader industry pattern.
Healthcare providers must halt the use of the affected x-ray systems immediately, which could disrupt patient care and operational workflows.
The serial number can typically be found on the device's back or side panel.
Expect a response for refunds or replacements within 4-6 weeks after contacting Canon Medical System.
Keep records of your device's serial number, purchase receipt, and any communication with the manufacturer.
The recalled models include serial numbers: D2A1672385, A2A20Z2165, and B2A1692426. These devices have been distributed worldwide, including the United States and the Dominican Republic.
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