Medical Device Recall: MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Siemens Medical Solutions USA, Inc · October 1, 2025
Reason for Recall
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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.
Distribution
US distribution to California. International distribution to Australia, Germany, Great Britian.
Quantity Affected
4 system (1 US; 3 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0431-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.