# FDA recall Z-0516-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-10-12.

## Product

Artis icono biplane with software VE20C-diagnostic imaging angiography system  Model: 11327600

## Reason for recall

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1.	Updated calibration data not saved with measurement after scene+/-; 2.	No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap;  4.	Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0516-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-12
- **Report date:** 2022-02-02
- **Termination date:** 2024-04-11

- **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-0516-2022

## Citation

> AI Analytics. FDA recall Z-0516-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0516-2022. Source: US FDA. Licensed CC0.

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