Recall Z-2500-2021 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by
| Date | Aug 18, 2021 |
| Status | Open, Classified |
| Reason | Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to US customers via CT024/21/S on 8/18/2021. The letter states reason for recall, helath risk and action to take: There are no workarounds available for the identified issues. Siemens Healthineers has developed software update syngo.CT VA30A_SP4 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide workflow improvements, bug fixes for the performance and stability problems observed in the installed base. The corrective action will be provid |
| Quantity | 31 units US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO Siemens Medical Solutions USA, Inc., Apr 1, 2020 |