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.
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens MAGNETOM Cima.X Upgrade: Ice Blockage Risk in Helium System.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51142-siemens-magnetom-cima-x-upgrade-ice-blockage-risk-in-helium. Based on FDA recall #Z-0431-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0431-2026%22&limit=1).
The FDA announced on Oct. 1, 2025, that Siemens Medical Solutions USA, Inc. is recalling the MAGNETOM Cima.X Upgrade due to a potential ice blockage in the venting system that could rupture the helium containment and cause a leak. This voluntary Class I recall affects one unit distributed to California.
How to tell if you have it
Brand: Siemens
Product: MAGNETOM Cima.X Upgrade
Model Number: 11689304
UPC: 04056869975245
Serial Number: 237304
The hazard
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.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Canon Vantage Titan 3T MRI Systems Recall (Dec. 19, 2025), Canon Medical Vantage Galan 3T MRI Recall (Dec. 19, 2025), and I.T.S. Hand Locking Plates System (Jan. 23, 2026).
How to tell if you have this one
Check for model number 11689304 on the device. The UDI is (01)04056869975245(21)237304 and serial number 237304.
Brand
Siemens
Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model number 11689304 on the device.
Where it went and when
Where it was distributed
Distributed in California, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US distribution to California. International distribution to Australia, Germany, Great Britian.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0431-2026 (October 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0431-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.