# FDA recall Z-2555-2018

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2018-06-04.

## Product

Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486    Product Usage:  Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.

## Reason for recall

Possible failure of screws which hold the gas spring fixation bracket in place.  Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.

## Distribution

Worldwide Distribution US Nationwide in the states of :  CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX.      International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND,   FRANCE, GERMANY, HONGKONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, MALAYSIA, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN,THAILAND, TURKEY, UK

## Key facts

- **Recall number:** Z-2555-2018
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-04
- **Report date:** 2018-08-01
- **Termination date:** 2021-03-25

- **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-2555-2018

## Citation

> AI Analytics. FDA recall Z-2555-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2555-2018. Source: US FDA. Licensed CC0.

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