Z-1242-2026Class II

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

Name: Z-1242-2026 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities...
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-12-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-12-19 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS on 2025-12-19. FDA classified it as Class II and gives the reason as "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1242-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-02-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Root cause tag: software
FDA 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 in commerce: 2 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Product codes and lots: Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1242-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-03
Z-1240-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-03
Z-1241-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-03
Z-1242-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-03

Product code JAK

K251061Class IINAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc. / cleared 2025-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)