# FDA recall Z-2688-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-06-24.

## Product

syngo.via RT Image Suite with software versions  syngo.via VB30 or VB40

## Reason for recall

If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in  Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.

## Distribution

US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.

## Key facts

- **Recall number:** Z-2688-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-24
- **Report date:** 2020-07-29
- **Termination date:** 2023-04-05

- **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-2688-2020

## Citation

> AI Analytics. FDA recall Z-2688-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2688-2020. Source: US FDA. Licensed CC0.

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