Siemens Medical Solutions USA recalled one MRI scanner model due to a risk of helium leaks. The recall affects one unit distributed worldwide as of August 28, 2025. Users must stop using the device immediately and follow manufacturer instructions.
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 Spectra (CN) MRI scanner, Model Number: 10655588. This unit is part of a global distribution, including the U.S. and numerous other countries. No retail price is specified.
The device may develop an ice blockage in the venting system. In the event of a quench, helium gas cannot escape, leading to a pressure build-up and potential rupture of the containment system.
No specific incidents of injury or death have been reported. The recall is classified as Class I, indicating a high hazard.
Stop using the MRI scanner immediately. Contact Siemens Medical Solutions USA, Inc. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2663-2025.
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