Siemens Medical Solutions Recalls NAEOTOM Alpha Software Applications Over Missing FDA Clearance
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 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).
Source: FDA Official Notice