MAGNETOM Cima — Class I medical device recall Z-0431-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2025-11-19, distributed in CA. There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary ve
| Recall number | Z-0431-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-10-01 |
| Classified | 2025-11-12 |
| Reported by FDA | 2025-11-19 |
| Distributed | CA |
| Countries outside the US | AU, DE |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04056869975245 |
| Serial numbers | 237304 |
| Model numbers | 11689304 |
Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0431-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.