# FDA recall Z-2262-2020

> **Ventana Medical Systems Inc** · Class II · device recall initiated 2019-10-04.

## Product

Model  Number:  06917259001 UDI:  04015630976010 - Product Usage:  The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

## Reason for recall

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board.  This can cause an electrical short and result in burned components.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of  AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MD, MI, MA, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, PA, PR, SC,  SD, TN, TX, UT, VA, WA, WI and the countries of   Australia, Austria, Belgium, Brazil, Canada, Chile, China,  Columbia, Costa Rica, Croatia, Denmark, Ecuador, El Salvador, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Kuwait, Lebanon, Malaysia, Norway, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-2262-2020
- **Recalling firm:** Ventana Medical Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-10-04
- **Report date:** 2020-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oro Valley, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2262-2020

## Citation

> AI Analytics. FDA recall Z-2262-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-2262-2020. Source: US FDA. Licensed CC0.

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