# FDA recall Z-0431-2026

> **Siemens Medical Solutions USA, Inc** · Class I · device recall initiated 2025-10-01.

## 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.

## Distribution

US distribution to California. International distribution to Australia, Germany, Great Britian.

## Key facts

- **Recall number:** Z-0431-2026
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-01
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0431-2026

## Citation

> AI Analytics. FDA recall Z-0431-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0431-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*