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 recalled models include serial numbers: D2A1672385, A2A20Z2165, and B2A1692426. These devices have been distributed worldwide, including the United States and the Dominican Republic.
Loose fixing screws in the ceiling movement gear can lead to the inability to move the device laterally. This defect may also cause abnormal noise and display sensor errors.
No injuries or incidents have been reported to date. The class II recall indicates a high hazard level for users.
Stop using the affected devices immediately. Contact Canon Medical System, USA, INC. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1178-2026 or contact Canon Medical System directly.
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