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.
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The VANTAGE TITAN 3T is an MRI system used for medical imaging. Hospitals and clinics use it for diagnosing various conditions through detailed imaging.
Ice formation in the venting system can lead to a dangerous pressure build-up if helium gas cannot escape properly. This poses a risk of helium release into the scanning room.
This recall is not part of a broader industry pattern.
The recall necessitates immediate cessation of use of the affected devices, impacting medical facilities and patient care.
The model number and UDI-DI code can typically be found on the back or side of the MRI system.
Expect a response regarding refunds or replacements after contacting Canon Medical Systems, typically within a few weeks.
Keep a record of your communications with Canon Medical Systems and any relevant documentation regarding the MRI system.
The recalled models are VANTAGE TITAN 3T Model MRT-3010/MEXL-3010. The UDI-DI code is 04987670101649. These systems were distributed nationwide in states including CA, CO, FL, and TX.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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.
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.
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.
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.
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.
Canon Medical System, USA recalls 8 SPOT Fluoro digital radiography systems in the United States after a software defect could expose patients to unintended X-ray exposure. The issue occurs when the acquisition program changes and the default ROI causes the collimator and static image to partially cover the collimated area. Stop using the affected devices and follow manufacturer instructions for a