[pending] MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Pending LLM rewrite. Source: FDA_DEVICE Z-0431-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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