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
- Software Applications
- Model numbers
- Material Number: 11549431, UDI-DI: 04056869978741, Serial Numbers: 183047, 183051, 183048, 183050, 183046
- 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 Siemens software applications are designed for CT systems to assist in brain quantification and vessel hyperdensities analysis. Healthcare providers use these applications to enhance diagnostic capabilities in imaging.
Why This Is Dangerous
The applications did not receive FDA 510(k) clearance, meaning they have not been evaluated for safety and effectiveness, which poses potential risks in clinical use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience to healthcare providers relying on the software for patient diagnostics, necessitating alternative procedures.
Practical Guidance
How to identify if yours is affected
- Verify the model number against the recall list.
- Check the serial numbers of the software applications in use.
- Contact the healthcare provider for further instructions.
Where to find product info
Serial numbers can typically be found in the software installation settings or documentation.
What timeline to expect
Expect a 4-6 week timeline for processing recall requests and any potential refunds.
If the manufacturer is unresponsive
- Document all communication attempts with Siemens Medical Solutions.
- Reach out again via different contact methods.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Ensure medical software has FDA clearance before use.
- Regularly check for updates and recalls of medical devices.
- Consult with trusted healthcare professionals for device safety.
Documentation advice
Keep records of the recall notice, receipts, and any correspondence with Siemens Medical Solutions.
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Product Details
The recall affects Siemens Medical software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. The affected software is associated with Material Number 11549431. The recall applies to five units identified by serial numbers 183046, 183047, 183048, 183050, and 183051.
Key Facts
- Recall date: December 19, 2025
- Report date: February 11, 2026
- Hazard classification: Class II
- Quantity recalled: 5 units
- Distribution: Worldwide including U.S., Canada, Costa Rica, India, Israel
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Safety Guide
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