Recall archive / FDA device enforcement
MAGNETOM Cima.X Upgrade. Model Number: 11689304. — FDA record Z-0431-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 1, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- 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.
- Classification
- Class I
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 4 system (1 US; 3 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0431-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to California. International distribution to Australia, Germany, Great Britian.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 19, 2025
- Recall initiation date
- Oct 1, 2025
- Center classification date
- Nov 12, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.