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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens MAGNETOM Cima.X Upgrade Recalled for Helium Venting Defect

Agency Publication Date: November 12, 2025
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Summary

Siemens Medical Solutions USA, Inc. is recalling 4 MAGNETOM Cima.X Upgrade systems (Model 11689304) due to a potential ice blockage in the magnet's helium venting paths. If a 'quench' occurs while these paths are blocked, helium gas cannot escape as designed, causing high pressure to build up inside the system. Because this is a specialized clinical device, facility managers and healthcare providers should stop using the system and contact the manufacturer to arrange for a correction.

Risk

The pressure build-up from a blocked venting path could cause the helium containment system to rupture. This would likely result in a helium leak directly into the patient scanning room, posing a risk of injury or asphyxiation.

What You Should Do

  1. The recalled product is the MAGNETOM Cima.X Upgrade, Model Number 11689304, with Serial Number 237304 and UDI (01)04056869975245(21)237304.
  2. Stop using the recalled device immediately.
  3. Contact Siemens Medical Solutions USA, Inc. or your authorized distributor to arrange for a system correction, return, or replacement.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MAGNETOM Cima.X Upgrade
Model / REF:
11689304
Serial Numbers:
237304
UDI:
(01)04056869975245(21)237304

Recall Number: Z-0431-2026. Affected quantity: 4 systems (1 in US, 3 international).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97845
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc.
Manufactured In: United States
Units Affected: 4 system (1 US; 3 OUS)
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.