# FDA recall Z-2500-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-08-18.

## Product

Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems:  SOMATOM go.Up - Model 11061620  SOMATOM go.Up - Model 11061628  SOMATOM go.All - Model 11061630  SOMATOM go.Top - Model 11061640  SOMATOM X.cite - Model 11330001    Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

## Reason for recall

Software versions may result in sporadic problems causing scanning workflow interruptions and  unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2500-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-18
- **Report date:** 2021-09-29

- **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-2500-2021

## Citation

> AI Analytics. FDA recall Z-2500-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2500-2021. Source: US FDA. Licensed CC0.

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