Recalls / —

—#218075

Product

NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K251061

Affected lot / code info

Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;

Why it was recalled

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On December 19, 2025, CUSTOMER ADVISORY NOTICE letters were sent to customers. Actions to be taken: 1. Stop all use of the Applications in patient care setting. 2. Please notify and instruct all staff at your organization who need to be aware of this matter. 3. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. 4. Please ensure that this advisory notice is retained in your product related records appropriately. Please keep this information until the corrective measures have been finalized. Actions by Siemens: Siemens Healthineers is expeditiously working to remove the Applications from your CT system(s) through a software update process. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436 if you have any questions.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

Timeline

Recall initiated

2025-12-19

Posted by FDA

2026-02-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #218075. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.