# FDA recall Z-3005-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-08-19.

## Product

Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK  Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

## Reason for recall

Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3005-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-19
- **Report date:** 2020-09-30
- **Termination date:** 2023-04-19

- **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-3005-2020

## Citation

> AI Analytics. FDA recall Z-3005-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3005-2020. Source: US FDA. Licensed CC0.

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