# FDA recall Z-0997-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-03-07.

## Product

syngo.via RT Image Suite  upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670.  Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

## Reason for recall

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-0997-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-07
- **Report date:** 2022-05-04
- **Termination date:** 2023-12-19

- **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-0997-2022

## Citation

> AI Analytics. FDA recall Z-0997-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0997-2022. Source: US FDA. Licensed CC0.

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