Siemens Medical Solutions Recalls NAEOTOM Alpha.Pro Software Applications Due to Lack of FDA Clearance
Siemens Medical Solutions USA, Inc. has issued a voluntary recall for specific NAEOTOM Alpha.Pro software applications that have not received required FDA 510(k) clearance.
What Happened
Siemens Medical Solutions USA, Inc. has initiated a voluntary recall of specific software applications associated with the NAEOTOM Alpha.Pro CT systems. The recall was launched because the applications—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 involves two units of the NAEOTOM Alpha.Pro software applications. Affected products are identified by the following details:
- Product Names: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, syngo.CT ASPECTS
- Material Number: 10191100
- UDI-DI: 04068151014655
- Serial Numbers: 258043, 258055
- Recall Number: Z-1242-2026
- Distribution: Worldwide distribution, including the United States, Canada, Costa Rica, India, and Israel.
What You Should Do
Siemens Medical Solutions USA, Inc. notified affected customers via a formal letter. The primary action required is the removal of the specified software applications from the CT systems. Facilities possessing these serial numbers should follow the instructions provided in the firm’s notification letter to ensure the uncleared software is decommissioned.
Why This Matters
This recall is necessary to ensure that all medical software used in clinical diagnostic settings has undergone the rigorous FDA review process required to verify its safety and effectiveness for patient care.
Source
Information provided by the FDA.
Source: FDA Official Notice