# FDA recall Z-2440-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-07-25.

## Product

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models:  SOMATOM Definition Edge-Model #10590000;  SOMATOM Definition AS Model #8098027;  SOMATOM Definition Flash Model #10430603

## Reason for recall

SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT  with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

## Distribution

Nationwide  Foreign:

## Key facts

- **Recall number:** Z-2440-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-25
- **Report date:** 2019-09-11
- **Termination date:** 2022-12-29

- **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-2440-2019

## Citation

> AI Analytics. FDA recall Z-2440-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2440-2019. Source: US FDA. Licensed CC0.

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