Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X Upgrade.
- Recalling company
- Siemens Medical Solutions USA, Inc
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Oct 1, 2025
- Reported
- Nov 19, 2025
- Distribution
- US distribution to California. International distribution to Australia, Germany, Great Britian.
- Status
- Ongoing
- Quantity
- 4 system (1 US; 3 OUS)
- Lot / codes
- Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
- Company location
- Malvern, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0431-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0431-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.