# FDA recall Z-1339-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-02-25.

## Product

syngo Application software VE20 (Material Number 10848815)  installed on the Artis pheno and Artis icono systems as follows:  (1) Artis pheno  Model Number:10849000  (2) Artis icono biplane  Model Number: 11327600  (3) Artis icono floor  Model Number: 11327700

## Reason for recall

After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes.  If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-1339-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-25
- **Report date:** 2022-07-13

- **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-1339-2022

## Citation

> AI Analytics. FDA recall Z-1339-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1339-2022. Source: US FDA. Licensed CC0.

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