# FDA recall Z-0469-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-10-21.

## Product

Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

## Reason for recall

Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-0469-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-21
- **Report date:** 2020-11-25
- **Termination date:** 2021-05-05

- **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-0469-2021

## Citation

> AI Analytics. FDA recall Z-0469-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0469-2021. Source: US FDA. Licensed CC0.

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