Siemens Medical Solutions USA recalled 237 MAGNETOM Vida MRI scanners on August 28, 2025. The recall stems from a potential ice blockage in the magnet venting system which may cause helium leaks. The affected model number is 11060815, distributed worldwide, including the U.S.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the MAGNETOM Vida MRI scanner with model number 11060815. It received multiple 510(k) clearances including K170396 and K220425. The scanners were distributed worldwide.
The potential for ice blockage in the magnet venting system poses a significant risk. If a quench occurs, helium gas may not escape through designated paths, leading to a pressure build-up that could rupture the helium containment system.
No injuries or incidents have been reported as of the recall date. The recall is classified as Class I due to the high hazard level.
Patients and healthcare providers must stop using the device immediately. Contact Siemens Medical Solutions USA or your healthcare provider for detailed instructions.
For more information, contact Siemens Medical Solutions USA, Inc. Visit the FDA website for additional recall details.
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