# FDA recall Z-0472-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-11-19.

## Product

SOMATOM Confidence -Computed tomography systems  Model 10590100

## Reason for recall

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0472-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-19
- **Report date:** 2022-01-19

- **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-0472-2022

## Citation

> AI Analytics. FDA recall Z-0472-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0472-2022. Source: US FDA. Licensed CC0.

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