HIGH

Siemens Medical Recalls CT Software Over FDA Clearance Issues

Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected 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 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

  1. Verify if you are using the SOMATOM X.ceed software applications mentioned in the recall.
  2. Check the material number and serial numbers against the recall notice.
  3. 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.

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
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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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: 11330002
UDI-DI: 04056869231051
Serial Numbers: 125205
125250
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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