Summary
The FDA issued a Class I for MAGNETOM Cima.X Upgrade. Model Number: 11689304. by Siemens Medical Solutions USA, Inc. 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 contain.
Details
Source
Device Recall
External ID
Z-0431-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Lot/Code Info: Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
Quantity Affected: 4 system (1 US; 3 OUS)
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.
Distribution
US distribution to California. International distribution to Australia, Germany, Great Britian.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-01
Company
Malvern, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 148 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0431-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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