FDA DevicesClass II
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo...
Published: February 11, 2026Recall ID: Z-1242-2026Category: devicesCountry: US
Reason for Recall / Hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Product Description & Identification
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Affected Products
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 98206 |
| Address 1 | 40 Liberty Blvd |
| Address 2 | N/A |
| Code info | Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055; |
| Postal code | 19355-1418 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 2 units |
| Reason for recall | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20260203 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.