# FDA recall Z-0984-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-02-08.

## Product

Uroskop Omnia -fluoroscopic X-ray system  Model # 10094910    The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

## Reason for recall

The swivel arm holding the monitors may become dislodged from the carrying arm.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0984-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-08
- **Report date:** 2019-03-13
- **Termination date:** 2020-05-05

- **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-0984-2019

## Citation

> AI Analytics. FDA recall Z-0984-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0984-2019. Source: US FDA. Licensed CC0.

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