Siemens Medical Solutions Recalls NAEOTOM Alpha Software Applications Over Missing FDA Clearance
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.
Siemens Medical Solutions USA, Inc. has issued a voluntary recall for software applications used with NAEOTOM Alpha CT systems because they lack required FDA 510(k) clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 18, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Siemens Medical Solutions USA, Inc. has initiated a voluntary recall to remove specific software applications from certain CT systems. The recall was triggered because the applications—syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS—have not received the necessary FDA 510(k) clearance for clinical use.
Which Products Are Affected
The recall affects 88 units of the NAEOTOM Alpha Software applications. The specific applications included in this action are:
- syngo.CT Brain Quantification
- syngo.CT Vessel Hyperdensities
- syngo.CT ASPECTS
Identification Details:
- Material Number: 11330003
- UDI-DI: 04056869263168
- Recall Number: Z-1240-2026
- Affected 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.
This recall impacts distribution nationwide in the U.S. and internationally in Canada, Costa Rica, India, and Israel.
What You Should Do
Siemens Medical Solutions USA, Inc. notified affected customers via a formal letter initiated on December 19, 2025. The firm is actively working to remove the unauthorized software applications from the identified CT systems. Healthcare providers and facilities using the NAEOTOM Alpha system should verify if their serial number is on the affected list and follow all instructions provided in the manufacturer's notification letter regarding software removal.
Why This Matters
This recall is classified as Class II, indicating that the use of the unauthorized software could potentially lead to temporary or medically reversible health consequences. It ensures that all medical diagnostic tools meet stringent FDA safety and efficacy standards before clinical implementation.
Source
Information provided by the U.S. Food and Drug Administration (FDA).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.
What is this FDA recall about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more FDA Recalls updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category