FDA Device recall Z-1253-2021
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)S…
- FDA Device
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)S… by Siemens Medical Solutions Usa, citing 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 noti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-03 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
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)
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
Identifiers
| code_info | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2021%22
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