Siemens Medical Solutions USA recalled 18 MAGNETOM Skyra Fit BioMatrix MRI machines on August 28, 2025. The recall addresses a potential ice blockage in the magnet venting system, which could lead to helium gas leaks. Users must stop using the devices 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
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The recalled model is the MAGNETOM Skyra Fit BioMatrix with model number 11516217. The devices were distributed worldwide, including the US and 75 other countries. Each unit is part of a broader recall affecting 18 machines.
An ice blockage can form in the magnet venting system, causing a risk of helium gas pressure build-up. This pressure may rupture the helium containment system, potentially resulting in a helium leak in the scanning room.
No incidents or injuries have been reported related to this recall as of now. The high hazard classification indicates a serious potential risk.
Stop using the MRI machines immediately. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for further instructions.
For more information, call Siemens Medical Solutions USA at 1-800-XXX-XXXX. Additional details can be found at the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2662-2025.
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