Siemens Medical Solutions Recalls NAEOTOM Alpha.Prime Software Applications Over Lack of FDA Clearance

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.