Siemens Medical Solutions USA, Inc medical device recall: MAGNETOM Cima.X Upgrade. Model Number: 11689304
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97845
- Recall initiated
- Oct 1, 2025
- Classified by FDA
- Nov 12, 2025
- Posted in Enforcement Report
- Nov 19, 2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Firm location
- Malvern, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Oct 1, 2025. FDA classified it 42 days later, on Nov 12, 2025. Distribution reported by FDA: US distribution to California. International distribution to Australia, Germany, Great Britian. Siemens Medical Solutions USA, Inc has 400 recalls in our records.
Recalled products (1)
Z-0431-2026 Class I Ongoing
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Codes / lots: Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Quantity: 4 system (1 US; 3 OUS)
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97845
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.