Recall Z-0372-2019 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
| Date | Oct 5, 2018 |
| Status | Terminated |
| Reason | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A., |
| Root cause | Other |
| Action | Siemens disseminated the notices by letter on 10/05/2018. Firm will deliver a Symbia Evo Excel Addendum and DVD addendum with this updated information at a later date. |
| Quantity | 264 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162337 | Symbia 6.5 Siemens Medical Solutions USA, Inc., Sep 8, 2016 |