# FDA recall Z-0406-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-10-07.

## Product

Software versions syngo CT VB20 running on  the following Siemens SOMATOM CT Scanner.   SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM  Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM  Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus  (Model # 10267000) with software syngo CT VB20

## Reason for recall

Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0406-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-07
- **Report date:** 2019-11-20
- **Termination date:** 2022-11-14

- **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-0406-2020

## Citation

> AI Analytics. FDA recall Z-0406-2020. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0406-2020. Source: US FDA. Licensed CC0.

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