Siemens Medical Solutions USA, Inc — MAGNETOM Cima.X Upgrade. Model Number: 11689304.
⚠️ 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- October 1, 2025
US distribution to California. International distribution to Australia, Germany, Great Britian.
What's affected?
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Lot code
- Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Additional details
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 4 system (1 US; 3 OUS).
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