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: 10191100, UDI-DI: 04068151014655, Serial Numbers: 258043, 258055
- 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 NAEOTOM Alpha.Pro software applications assist in analyzing CT scans for brain quantification and vessel hyperdensities. Healthcare providers rely on such software for accurate diagnostics and treatment planning.
Why This Is Dangerous
The software's lack of FDA clearance means it has not been evaluated for safety and efficacy, posing risks in medical settings. Continued use could lead to improper diagnostics or treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must immediately cease use of the software, which may disrupt diagnostic processes and require alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check the material number: 10191100
- Verify the UDI-DI: 04068151014655
- Look for serial numbers: 258043 or 258055
Where to find product info
Serial numbers and identifiers can typically be found on the product packaging or within the software settings.
What timeline to expect
Refund processing timelines can vary; contact Siemens Medical Solutions for specific details.
If the manufacturer is unresponsive
- Follow up with Siemens Medical Solutions via phone or email.
- Consult your healthcare provider for alternative solutions.
How to prevent similar issues
- Ensure any medical software has FDA clearance before use.
- Stay informed about product recalls related to medical devices.
Documentation advice
Keep records of correspondence with Siemens Medical Solutions and documentation of the product.
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Product Details
The recall involves NAEOTOM Alpha.Pro software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. These applications have not received the necessary FDA 510(k) clearance. The products were distributed worldwide, including the US, Canada, Costa Rica, India, and Israel.
Key Facts
- Recall date: December 19, 2025
- Report date: February 11, 2026
- Affected models: Material Number 10191100, UDI-DI 04068151014655
- Distribution: US, Canada, Costa Rica, India, Israel
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Safety Guide
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