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
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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.
The venting system of the superconducting magnet may form ice. If a quench occurs, helium gas may not escape, causing pressure to rise and potentially rupture the helium vessel.
No injuries or incidents have been reported to date related to this defect. The recall is classified as Class II, indicating a moderate risk.
Healthcare providers should stop using the affected MRI systems immediately. Follow the manufacturer's recall instructions and contact Canon Medical Systems for further guidance.
For more information, contact Canon Medical Systems, USA, INC. or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1018-2026.
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