MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Pending LLM rewrite. Source: FDA_DEVICE Z-0431-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Devices
Distribution
Distribution scope not specified by the agency.
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