Siemens Medical Solutions USA recalled 71 MRI machines on August 28, 2025. Ice blockages in the venting system may cause helium leaks. The recall affects models 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
The recall involves MAGNETOM Lumina (DE) MRI machines, Model Number: 11344916. These units were sold worldwide, including the U.S. The machines are part of a Class I recall.
Ice blockages may form in the magnet venting system, preventing helium gas from escaping. This could lead to a pressure build-up and potential rupture of the helium containment system, resulting in a helium leak.
There are no specific injury or incident reports associated with this recall. The potential hazard poses a significant risk to patient and staff safety.
Stop using the MAGNETOM Lumina MRI machines immediately. Follow the recall instructions provided by Siemens Medical Solutions and contact your healthcare provider.
For instructions, contact Siemens Medical Solutions USA, Inc. at their official website or refer to the recall letter sent to healthcare providers.
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