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 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.
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