Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Medical Solutions USA
- Product type
- CT Software Applications
- Model numbers
- Material Number: 11330002, UDI-DI: 04056869231051, Serial Numbers: 125205, 125250
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The SOMATOM X.ceed software applications are used in medical imaging to assist in brain assessment. Healthcare providers purchase these applications to enhance diagnostic capabilities in CT scans.
Why This Is Dangerous
The lack of FDA clearance means these software applications have not been validated for safety and effectiveness, which can pose significant risks during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers must stop using the software immediately, which can disrupt patient care and diagnostic processes.
Practical Guidance
How to identify if yours is affected
- Verify if you are using the SOMATOM X.ceed software applications mentioned in the recall.
- Check the material number and serial numbers against the recall notice.
- Contact Siemens Medical Solutions for confirmation of your software's status.
Where to find product info
Serial numbers and material numbers can typically be found in the software's settings or on the packaging.
What timeline to expect
Expect a response from Siemens Medical regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Siemens Medical Solutions via phone or email.
- Contact the FDA or relevant health authorities if no response is received.
How to prevent similar issues
- Always verify FDA clearance for medical software before use.
- Keep up-to-date with manufacturer recalls and safety notices.
- Consult with healthcare professionals for approved software recommendations.
Documentation advice
Keep records of all communications with Siemens Medical, including emails and letters regarding the recall.
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Product Details
The recall involves SOMATOM X.ceed software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. A total of two units are affected. These applications were distributed worldwide, including throughout the US, Canada, Costa Rica, India, and Israel.
Key Facts
- Recall date: December 19, 2025
- Report date: February 11, 2026
- Affected models: Material Number 11330002, Serial Numbers 125205, 125250
- FDA classification: Class II
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Safety Guide
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