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.
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 recall involves VANTAGE GALAN 3T MRI systems, models MRT-3020 and MEXL-3020. These units were distributed nationwide in California, Colorado, Florida, and other states. The systems were sold primarily to healthcare providers.
The MRI systems may develop ice in the venting system of the superconducting magnet. If a quench occurs, pressure may build in the helium vessel, potentially rupturing it and releasing helium gas into the MR scanning room.
No injuries or incidents have been reported. The recall is classified as Class II due to the potential hazards associated with the helium gas release.
Stop using the MRI systems immediately. Follow the recall instructions provided by Canon Medical Systems. Contact your healthcare provider or Canon Medical for further instructions.
For further information, contact Canon Medical Systems, USA, at 1-800-XXX-XXXX or visit their website.
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