Device product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Z-0431-2026
Product summary
- Event
- Event 97845
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4 system (1 US; 3 OUS)
- Official record key
device-enforcement:Z-0431-2026
Official wording
Reason: 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.
Code information: Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Distribution pattern: US distribution to California. International distribution to Australia, Germany, Great Britian.
Derived failure modes
-
Unknown
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.