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: 11330003, UDI-DI: 04056869263168, Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313 +12 more
- 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
NAEOTOM Alpha software applications are used in CT imaging to assess brain quantification and vessel hyperdensities. Healthcare providers purchase these applications to enhance diagnostic accuracy in medical imaging.
Why This Is Dangerous
The software applications have not received FDA 510(k) clearance, which is necessary to ensure they meet safety and efficacy standards. Without this clearance, there is a risk of inaccurate diagnoses or treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers using the NAEOTOM Alpha software, necessitating an immediate halt in usage. This may disrupt medical imaging services and could lead to delays in patient care.
Practical Guidance
How to identify if yours is affected
- Locate the material number 11330003 on your software documentation.
- Check the serial numbers against the recalled list provided by Siemens.
- Contact your healthcare provider for assistance in identifying affected software.
Where to find product info
The material number and serial numbers can typically be found on the product packaging or documentation provided with the software.
What timeline to expect
Expect a timeline of 4-6 weeks for any guidance or updates from Siemens regarding the recall.
If the manufacturer is unresponsive
- Document all correspondence with Siemens Medical Solutions USA.
- Consider escalating your concerns to the FDA or relevant health authority if needed.
How to prevent similar issues
- Always check for FDA clearance before purchasing medical software.
- Stay informed about recalls and safety notices through official channels.
- Consult with healthcare regulatory bodies for updated information on medical devices.
Documentation advice
Keep a record of all communications regarding the recall, including emails, letters, and notes from phone calls.
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Product Details
The recall affects NAEOTOM Alpha software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. The software was distributed worldwide, including the US, Canada, Costa Rica, India, and Israel.
Key Facts
- Recall date: December 19, 2025
- Quantity recalled: 88 units
- Affected countries: US, Canada, Costa Rica, India, Israel
- No reported injuries, but high hazard level
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