# FDA recall Z-1253-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-03-03.

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1253-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-03
- **Report date:** 2021-03-24
- **Termination date:** 2023-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1253-2021

## Citation

> AI Analytics. FDA recall Z-1253-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1253-2021. Source: US FDA. Licensed CC0.

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