FDA-Device2025-11-19Class IPROCESSING DEFECT
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to California. International distribution to Australia, Germany, Great Britian.
Affected count
4 system (1 US; 3 OUS)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0431-2026More Siemens recalls
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