FDA recall, , Moderate risk
Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications
CT software applications lack FDA clearance and may be removed from certain systems.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, recalled certain NAEOTOM Alpha.Pro, NAEOTOM Alpha.Prime, NAEOTOM Alpha, and SOMATOM X.ceed software applications because the applications have not received FDA 510(k) clearance. The recall began December 19, 2025, and was added to the FDA's Enforcement Report on February 3, 2026, with nationwide distribution in the US and worldwide in Canada, Costa Rica, India, and Israel.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT Aspects
- UDI-DI
- 10191100
- 04068151014655
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT Aspects
- UDI-DI
- 11549431
- 04056869978741
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT Aspects
- UDI-DI
- 11330003
- 04056869263168
Somatom X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT Aspects
- UDI-DI
- 11330002
- 04056869231051
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
- Company
- Siemens Medical Solutions USA, IncMalvern, Pennsylvania
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98206
- Recall numbers
- Z-1239-2026 to Z-1242-2026
All recalls from Siemens Medical Solutions USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary