Siemens Medical Solutions USA recalled one BIOGRAPH One MRI system on August 28, 2025. The recall affects model number 11689172 due to a potential helium leak risk. Patients and healthcare providers must stop using the device immediately and follow the manufacturer’s 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 recalled product is the BIOGRAPH One (DE) MRI system, model number 11689172, with UDI number (01)4068151020472(21)238008. One unit was distributed worldwide, including in the US and several international markets. The price information is not disclosed.
The device has a risk of ice blockage forming in the magnet venting system. If a quench occurs, helium gas may not escape properly, leading to a dangerous pressure build-up that could rupture the system.
No injuries or incidents have been reported related to this recall so far. The potential for a helium leak poses a significant hazard in medical environments.
Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided by Siemens Medical Solutions USA or consult their healthcare provider for further guidance.
For more information, contact Siemens Medical Solutions USA, Inc. For recall instructions, visit the FDA website or check the notification letter.
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