Siemens Medical Solutions Recalls NAEOTOM Alpha.Prime Software Applications Over Lack of FDA Clearance
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Siemens Medical Solutions USA, Inc. has initiated a voluntary recall of software applications for NAEOTOM Alpha.Prime CT systems because they have not received required FDA 510(k) clearance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Siemens Medical Solutions USA, Inc. has initiated a voluntary recall of specific software applications associated with its NAEOTOM Alpha.Prime CT systems. The recall was issued because the software applications—specifically syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS—were distributed without receiving the necessary FDA 510(k) clearance.
Which Products Are Affected
The recall affects five units of the NAEOTOM Alpha.Prime software applications. Affected products are identified by the following details:
- Product Name: 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
- Recall Number: Z-1241-2026
The distribution of these units was worldwide, including the United States, Canada, Costa Rica, India, and Israel.
What You Should Do
Siemens Medical Solutions USA, Inc. initiated the recall on December 19, 2025, by sending notification letters to affected customers. Facilities utilizing the NAEOTOM Alpha.Prime systems with the specified serial numbers should follow the instructions provided in the firm's notification letter regarding the removal of the unauthorized software applications from their systems.
Why This Matters
This recall is significant because medical software used for diagnostic purposes must undergo FDA 510(k) clearance to ensure it meets safety and effectiveness standards. Using unvetted software in a clinical environment could lead to regulatory non-compliance and potential risks regarding the accuracy of clinical tools.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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