NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 19, 2025 |
| Reported | February 11, 2026 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Country / region | United States PA |
Hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Affected products
- NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
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