HIGH

Siemens Medical Solutions Recalling CT Software Over Clearance Issues

Siemens Medical Solutions USA recalled two units of its NAEOTOM Alpha.Pro software applications on December 19, 2025. The recall affects software used in CT systems that lack FDA 510(k) clearance. Healthcare providers and patients must stop using the software immediately.

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

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

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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

  1. Check the material number: 10191100
  2. Verify the UDI-DI: 04068151014655
  3. 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.

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
  • Serial numbers: 258043, 258055
  • Distribution: US, Canada, Costa Rica, India, Israel
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCT Software Applications
Sold At
Multiple Retailers

Product Details

Model Numbers
Material Number: 10191100
UDI-DI: 04068151014655
Serial Numbers: 258043
258055
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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