Siemens Medical Solutions USA recalled 23 units of the Biograph mMR on August 28, 2025, due to a potential helium leak risk. The recall affects devices distributed worldwide, including the US. This Class I recall poses a high hazard to patients and healthcare providers.
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 includes model number 10433372, with UDI numbers ranging from (01)04056869006741(21)151004 to (01)04056869006741(21)51048. The product is distributed worldwide, including the United States and several countries across multiple continents. Specific pricing information is not available.
An ice blockage could form within the magnet venting system. If a quench occurs, helium gas may fail to escape, leading to pressure build-up and potential rupture of the containment system.
No specific incidents or injuries have been reported related to this recall at this time. However, the hazard level remains classified as high.
Patients and healthcare providers must stop using the Biograph mMR immediately. Contact Siemens Medical Solutions USA for further instructions.
For more information, contact Siemens Medical Solutions USA at 1-800-XXX-XXXX or visit their website.
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