# FDA recall Z-0119-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-09-20.

## Product

ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

## Reason for recall

Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-0119-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-20
- **Report date:** 2022-11-02

- **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-0119-2023

## Citation

> AI Analytics. FDA recall Z-0119-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0119-2023. Source: US FDA. Licensed CC0.

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