Siemens Medical Solutions USA, Inc: MAGNETOM Cima.X Upgrade. Model Number: 11689304.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Siemens Medical Solutions USA, Inc
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US distribution to California. International distribution to Australia, Germany, Great Britian.
- Recall initiated
- 2025-10-01
- Code info
- Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
- Product quantity
- 4 system (1 US; 3 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Malvern
- State
- PA
- Country
- United States
- Event id
- 97845
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