FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Recall number
- Z-1241-2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Status
- Open, Classified
- Initiated
- 2025-12-19
- Posted
- 2026-02-03
- Terminated
- not on file
- Reason
- To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 5 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- Lot, serial or model codes
- Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;
- 510(k) numbers
- ["K251061"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28