NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Recall
- Recall Number
- Z-1241-2026
- Event Number
- 98206
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAK
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 19, 2025
- Posted
- February 3, 2026
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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.
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
5 units