Use caution Medical device recall · FDA · Published December 19, 2025

Siemens CT Software Apps Recalled: Unapproved Medical Use Without FDA Clearance

Siemens Medical Solutions recalls unapproved CT software applications that lack FDA 510(k) clearance. Affected users should stop using these applications until a fix is available.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1242-2026Medical device Siemens ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling specific CT software applications that have not received FDA clearance. Using these unapproved software tools could pose risks to patient safety and medical procedures. Read more at govinfonow.com/recall/50377-siemens-ct-software-apps-recalled-unapproved-medical-use-without-fda.

Source Summary by GovInfoNow · govinfonow.com/recall/50377-siemens-ct-software-apps-recalled-unapproved-medical-use-without-fda · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1242-2026

Cite this page

“Siemens CT Software Apps Recalled: Unapproved Medical Use Without FDA Clearance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50377-siemens-ct-software-apps-recalled-unapproved-medical-use-without-fda. Based on FDA recall #Z-1242-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2026%22&limit=1).

The FDA announced on Dec. 19, 2025, that Siemens Medical Solutions USA, Inc. is recalling NAEOTOM Alpha.Pro software applications due to lack of required 510(k) clearance. The agency classified the recall as Class II.

How to tell if you have it

Brand: Siemens
Product: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, syngo.CT ASPECTS
Material Number: 10191100
UDI-DI: 04068151014655
Serial Numbers: 258043, 258055

The hazard

The recall addresses software applications that have not received FDA 510(k) clearance. This lack of clearance constitutes the hazard for the affected CT systems.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar recalls include Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK (Feb. 25, 2026), Medline Angiography Kits (Feb. 25, 2026), and DFI One Step 10A In Vitro Diagnostic Test (April 2, 2026).

How to tell if you have this one

Check for the software names: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, or syngo.CT ASPECTS. The material number 1019110:00 and serial numbers 258043 or 258055 indicate the affected units.

Brand
Siemens
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

Recall number	Product, codes & lots	Quantity
Z-1239-2026	SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS; Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;	2 units
Z-1240-2026	NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS; Material Number: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169;	88 units
Z-1241-2026	NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS; Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;	5 units
Z-1242-2026	NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS; Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;	2 units

Based on the official FDA remedy

What to do — step by step

Stop Using Unapproved Software
Immediately stop using the recalled syngo.CT software applications as they lack FDA clearance.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 54 days after the firm started it.

Dec 19, 2025Firm started the recall
Feb 3, 2026FDA classified it Class II
Feb 11, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50377-siemens-ct-software-apps-recalled-unapproved-medical-use-without-fda">Siemens CT Software Apps Recalled: Unapproved Medical Use Without FDA Clearance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1242-2026 (December 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1242-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.