# FDA recall Z-1245-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-02-14.

## Product

SOMATOM Definition Edge, Model Number 10590000    Product Usage:  Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

## Reason for recall

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1245-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-14
- **Report date:** 2019-05-08
- **Termination date:** 2020-05-01

- **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-1245-2019

## Citation

> AI Analytics. FDA recall Z-1245-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1245-2019. Source: US FDA. Licensed CC0.

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