Software versions syngo — Class II medical device recall Z-1253-2021

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-03-24, distributed nationwide. SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic prob

Recall number	`Z-1253-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated	2021-03-03
Classified	2021-03-15
Reported by FDA	2021-03-24
Terminated	2023-12-28
Distributed	Nationwide (US)
Quantity	190 units
Reason classes	software
Model numbers	`11061610`, `11061620`, `11061628`, `11061630`, `11061640`, `11061648`, `11061660`, `11061670`, `11330001`

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1253-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.