Siemens Medical Solutions USA recalled nine MRI scanners on August 28, 2025. The devices may develop ice blockages in the venting system, risking helium leaks. Healthcare providers must stop using the scanners immediately.
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 recall involves the MAGNETOM Cima.X (DE), Model Number: 11647158. The units were distributed worldwide, including the US and multiple countries, with a total of nine units recalled.
The MRI scanners may experience ice blockages in the magnet venting system. In the event of a quench, helium gas could become trapped, leading to a dangerous pressure build-up and potential rupturing of the helium containment system.
No specific injuries or incidents have been reported at this time. The risk of helium leaks poses a significant hazard to patients and staff in scanning rooms.
Immediately stop using the affected MRI scanners. Follow the manufacturer's recall instructions and contact Siemens Medical Solutions USA for further guidance.
For more information, call Siemens Medical Solutions USA at 1-800-XXX-XXXX. Additional details can be found at the FDA's recall page.
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