Class I — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | MAGNETOM Cima.X Upgrade. Model Number: 11689304. |
| Quantity | 4 system (1 US; 3 OUS) |
| Distribution | US distribution to California. International distribution to Australia, Germany, Great Britian. |
| Initiated | 2025-10-01 |
| Classified | 2025-11-12 |
| Recall number | Z-0431-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Siemens Medical Solutions USA, Inc (Z-0431-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97845/
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