Recall Z-1003-2023 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11
| Date | Jan 20, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped |
| Root cause | Under Investigation by firm |
| Action | Siemens Customer Safety Advisory Notification CT083/22/S issued beginning on 12/23/2022 via email. Letter states reason for recall, health risk and action to take: When performing a CT intervention study, please make sure that the Recon parameter Image order is set to Head to Feet. Provides instruction on how to avoid the issue. Siemens is currently working on a permanent solution for this issue. This solution will be rolled out as a software update to all affected customers free of charge. Siemens is currently working on a permanent solution for this malfunction. This solution will be rolled |
| Quantity | 29 units U.S. |
| Distribution | Nationwide |
| 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 |
| K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and Siemens Medical Solutions USA, Inc., Aug 27, 2021 |
| K220814 | NAEOTOM Alpha, Scan&GO Software Siemens Medical Solutions USA, Inc., Jul 12, 2022 |