CLASS I ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
Magnetom Cima.X Upgrade recalled by Siemens Medical Solutions USA
Siemens Medical Solutions USA is recalling Magnetom Cima.X Upgrade, distributed in California. The recall was initiated on 1 Oct 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0431-2026
- FDA event ID
- 97845
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 1 Oct 2025
- FDA classified
- 12 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 1 Oct 2025 | Recall initiated by company | |
| 12 Nov 2025 | Classified by FDA | +42 days |
| 19 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Where it was distributed
US distribution to California. International distribution to Australia, Germany, Great Britian.
Questions about this recall
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.
Which lots are affected?
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Where was it sold?
US distribution to California. International distribution to Australia, Germany, Great Britian.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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