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

FDA device recall Z-1240-2026 · posted 2026-02-03 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAK

Quantity affected

88 units

Distribution

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

Date initiated

2025-12-19

Date posted

2026-02-03

Location

Malvern, PA

Related 510(k) clearances