# FDA recall Z-0922-2025

> **SIEMENS MEDICAL SOLUTIONS USA, INC** · Class II · device recall initiated 2025-01-02.

## Product

ARTIS One Angiographic X-Ray System

## Reason for recall

A potential issue with ARTIS One systems was identified. In very  rare situations, the first x-ray release following patient registration may be performed with incorrect  copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher  than intended by the user.

## Distribution

23 Distributed in the US

## Key facts

- **Recall number:** Z-0922-2025
- **Recalling firm:** SIEMENS MEDICAL SOLUTIONS USA, INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-02
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** —
- **Location:** Malvern, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2025

## Citation

> AI Analytics. FDA recall Z-0922-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0922-2025. Source: US FDA. Licensed CC0.

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