FDA recall Z-0431-2026

Siemens Medical Solutions USA, Inc · Class I · device

Product

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

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.

Key facts

Status
Ongoing
Initiation date
2025-10-01
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0431-2026