# FDA recall Z-0288-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-08-30.

## Product

SOMATOM Confidence with software syngo.CT VB20  Model #10590100

## Reason for recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4,  may result in workflow interruptions  resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0288-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-30
- **Report date:** 2021-12-01
- **Termination date:** 2024-01-16

- **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-0288-2022

## Citation

> AI Analytics. FDA recall Z-0288-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0288-2022. Source: US FDA. Licensed CC0.

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