# FDA recall Z-1247-2025

> **LEICA BIOSYSTEMS NUSSLOCH GMBH** · Class II · device recall initiated 2025-01-30.

## Product

Brand Name: Leica Biosystems Cryostats  Product Name: CM1950  Model/Catalog Number: 1491950C4US  Software Version: firmware V3.01

## Reason for recall

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

## Distribution

Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.

## Key facts

- **Recall number:** Z-1247-2025
- **Recalling firm:** LEICA BIOSYSTEMS NUSSLOCH GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-30
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nussloch, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2025

## Citation

> AI Analytics. FDA recall Z-1247-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1247-2025. Source: US FDA. Licensed CC0.

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