# FDA recall Z-1333-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-01-08.

## Product

Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.

## Reason for recall

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in  collision control creating risk of collision with obstacles or persons when the operator uses the override function.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1333-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-08
- **Report date:** 2020-02-26
- **Termination date:** 2022-06-21

- **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-1333-2020

## Citation

> AI Analytics. FDA recall Z-1333-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-1333-2020. Source: US FDA. Licensed CC0.

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