# FDA recall Z-0806-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-09-09.

## Product

Uroskop Omnia Max, Model no. 10762473 - Product Usage: 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

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0806-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-09
- **Report date:** 2021-01-20
- **Termination date:** 2021-04-16

- **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-0806-2021

## Citation

> AI Analytics. FDA recall Z-0806-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0806-2021. Source: US FDA. Licensed CC0.

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