FDA Medical devices recall ·
MAGNETOM Cima.X Upgrade recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0431-2026
- Date
- (initiated October 1, 2025)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4 system (1 US; 3 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Distribution
US distribution to California. International distribution to Australia, Germany, Great Britian.
States: California
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0431-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.