Siemens Medical Solutions USA recalled 30 units of the MAGNETOM Skyra fit MRI system on August 28, 2025. The recall addresses a potential ice blockage in the magnet venting system that could lead to a helium leak. The device is distributed worldwide, including the US and multiple countries.
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 recalled product is the MAGNETOM Skyra fit, Model Number 10849580. This MRI system was distributed worldwide, including the US, since its manufacturing date. Specific UDI numbers include (01)04056869006710(21)170068 and others.
The MRI system may experience an ice blockage in the magnet venting system. This blockage can prevent helium gas from escaping, leading to a dangerous pressure build-up and potential rupture of the helium containment system.
As of now, there are no reported injuries or incidents linked to this recall. The potential for helium leaks poses a significant risk to patients in the scanning room.
Immediately stop using the MAGNETOM Skyra fit MRI system. Follow the recall instructions from Siemens Medical Solutions. Contact your healthcare provider for further instructions.
For more information, contact Siemens Medical Solutions USA, Inc. at their official website or customer service.
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