Recall Z-1253-2021 · JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)
| Date | Mar 3, 2021 |
| Status | Terminated |
| Reason | SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take: Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improve |
| Quantity | 190 units US |
| Distribution | US Nationwide distribution. |
| 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 |