Recall Z-1241-2026 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
| Date | Feb 3, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| Root cause | Under Investigation by firm |
| Action | On December 19, 2025, CUSTOMER ADVISORY NOTICE letters were sent to customers. Actions to be taken: 1. Stop all use of the Applications in patient care setting. 2. Please notify and instruct all staff at your organization who need to be aware of this matter. 3. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. 4. Please ensure that this advisory notice is retained in your product related records appropria |
| Quantity | 5 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime Siemens Medical Solutions USA, Inc., Jul 28, 2025 |