# FDA recall Z-1849-2022

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2022-08-26.

## Product

Leica Surgical Operating Microscopes, Arveo, Part Number 10448999

## Reason for recall

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1849-2022
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-26
- **Report date:** 2022-10-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2022

## Citation

> AI Analytics. FDA recall Z-1849-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1849-2022. Source: US FDA. Licensed CC0.

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