# FDA recall Z-2271-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-07-03.

## Product

SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

## Reason for recall

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2271-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-03
- **Report date:** 2019-08-21
- **Termination date:** 2024-05-10

- **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-2271-2019

## Citation

> AI Analytics. FDA recall Z-2271-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2271-2019. Source: US FDA. Licensed CC0.

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