Canon Medical System, USA Recalls

7 recalls found for Canon Medical System, USA. Check if any of your products are affected.

HIGHFDA DEVICE

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.

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HIGHFDA DEVICE

Canon Medical Recalls Interventional X-Ray System Over Safety Risk

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.

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HIGHFDA DEVICE

Canon Medical System Recalls Interventional X-Ray Systems Over Safety Risk

Canon Medical System, USA recalled 332 units of the Alphenix INFX-8000V X-ray system on December 19, 2025. Loose fixing screws may hinder ceiling movement and cause sensor errors. Healthcare providers must stop using the device immediately and follow manufacturer's instructions.

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HIGHFDA DEVICE

Canon Medical Recalls Interventional X-ray System Over Safety Hazard

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.

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HIGHFDA DEVICE

Canon Medical MRI Systems Recalled Over High-Pressure Risk

Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.

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HIGHFDA DEVICE

Canon Medical Recalls Alphenix INFX-8000C X-Ray System Over Safety Risk

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.

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Brand Statistics

Total Recalls
7
Pages
1