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 VANTAGE GALAN 3T MRI systems are advanced imaging devices used in hospitals and clinics for diagnostics. These systems are essential in providing high-quality imaging for patients.
The venting system in the superconducting magnet may form ice, leading to a dangerous pressure build-up if a quench occurs. This can result in a rupture of the helium vessel, releasing helium gas.
This recall is not part of a broader industry pattern.
Healthcare providers must stop using these MRI systems immediately, affecting diagnostic services and potentially delaying patient care.
Look for the model number and UDI-DI code on the manufacturer's label attached to the MRI system.
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.
Keep records of your purchase, any communication with the manufacturer, and documentation of the recall.
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.
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