Recall Z-0962-2022 · JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
| Date | Mar 7, 2022 |
| Status | Open, Classified |
| Reason | Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via CT010/22/S via email/mail on March 7, 2022. Letter states reason for recall, health risk and action to take: There are no workarounds for these issues. Customers are urged to install the remote update as soon as it is released. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens has developed software update syngo CT VA30A_SP5 to ensure more stable scanning workflows, reduce the number of user notifications, and to further improve the image |
| Quantity | 547 units US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163296 | SOMATOM go.Up, SOMATOM go.Now Siemens Medical Solutions USA, Inc., Mar 21, 2017 |
| K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc., Apr 13, 2018 |
| K192061 | SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO Siemens Medical Solutions USA, Inc., Nov 21, 2019 |
| 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 |