# FDA recall Z-0838-2019

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2017-09-25.

## Product

PROVEO 8 Ophthalmic Microscope System  optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

## Reason for recall

The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit.  Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0838-2019
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-25
- **Report date:** 2019-02-27
- **Termination date:** 2020-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buffalo Grove, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0838-2019

## Citation

> AI Analytics. FDA recall Z-0838-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0838-2019. Source: US FDA. Licensed CC0.

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