Recall Z-1245-2019 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
| Date | Feb 14, 2019 |
| Status | Terminated |
| Reason | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube. |
| Root cause | Software design |
| Action | Siemens issued letter dated 2/14/19 providing reason for recall and a user workaround in the Customer Safety Advisory Notice (CSAN) CT006/19/S. The recall issue will be permanently resolved by software update syngo CT VB10A_SP1. Contact the service organization 1-800-888-7436. |
| Quantity | 53 total units distributed in U.S. |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Dei Siemens Medical Solutions USA, Inc., Mar 30, 2018 |