Siemens Medical Solutions USA recalled 39 MAGNETOM Prisma MRI scanners on August 28, 2025, due to a potential helium leak hazard. The recall affects units distributed worldwide, with a significant risk of helium gas build-up within the containment system. Healthcare providers must stop using the device immediately and follow recall 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
The recall involves the MAGNETOM Prisma MRI Scanner, Model Number: 10849582. The affected units include UDI Numbers: (01)04056869006727(21)66104, (01)04056869006727(21)66109, and more. The device was distributed worldwide, including the US and numerous other countries.
The MRI scanner poses a high hazard due to the risk of ice blockage forming within the magnet venting system. In the event of a quench, helium gas may not escape as intended, leading to pressure build-up and potential rupture of the containment system.
There are no reported incidents or injuries associated with this recall at this time. The potential for a helium leak into the scanning room is the primary concern.
Patients and healthcare providers must stop using the scanner immediately. Contact Siemens Medical Solutions USA or your healthcare provider for detailed instructions and follow the recall guidelines.
For assistance, contact Siemens Medical Solutions USA at 1-800-XXX-XXXX. More information is available on the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2659-2025.
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