What should I do if I use the Siemens software applications?

Stop using the software immediately and follow the recall instructions provided by Siemens Medical Solutions. Contact your healthcare provider for further guidance.

Are there any reported injuries from this recall?

No injuries or incidents have been reported related to the use of the affected software applications.

How can I find out if my software is affected?

Check if your software corresponds to the affected models listed in the recall notice. If in doubt, consult your healthcare provider.

What is the FDA 510(k) clearance?

FDA 510(k) clearance is a premarket submission to the FDA that demonstrates that the device is safe and effective, and is substantially equivalent to a legally marketed device.

Where can I get more information about this recall?

Visit the FDA's recall page or contact Siemens Medical Solutions USA, Inc for detailed instructions and information.

What are the consequences of using this software without FDA clearance?

Using software that lacks FDA clearance may expose patients to unverified risks and potentially inaccurate medical assessments.

Will I receive a refund for the affected software?

Refund procedures will depend on your specific agreement with Siemens Medical Solutions. Contact them directly for any refund inquiries.

How long will it take to process my recall request?

The timeline for processing recall requests may vary. Expect typical processing times of 4-6 weeks.

Can I continue using the software if it seems to work fine?

No, you should not continue using the software as it lacks the necessary FDA clearance, regardless of its current functionality.

What if I have more questions about the recall?

You can reach out to Siemens Medical Solutions directly or consult your healthcare provider for more detailed inquiries.

HIGHDecember 19, 2025

Siemens Medical Recalls Software Due to Lack of FDA Clearance

Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.

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 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.

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

View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeSoftware Applications

Product Details

Brand

Siemens Medical Solutions USA

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