# FDA recall Z-0477-2023

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2022-11-21.

## Product

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

## Reason for recall

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0477-2023
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-21
- **Report date:** 2022-12-21

- **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-0477-2023

## Citation

> AI Analytics. FDA recall Z-0477-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0477-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*