Siemens Medical Solutions USA, Inc Recall 87454
Description: 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)
Siemens Medical Solutions USA, Inc Recall 87454 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1253-2021 |
| Event ID | 87454 |
| Event Description | 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) |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 190 units US |
| Recall 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 |
| Device Classification | 20210324 |
| Device Code Info | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a |
| Center Classification Date | 20210315 |
| Recall Initiation Date | 20210303 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | |
| Similar To |