# FDA recall Z-1374-2022

> **Ventana Medical Systems Inc** · Class II · device recall initiated 2022-06-01.

## Product

Ventana HE 600 System, automated slide preparer, for use in laboratories.

## Reason for recall

There is a potential for fluid leak  inside the Ventana HE 600 instrument which could result in electrical short and fire

## Distribution

US: AL	AR	AZ	CA	CO	CT	DC	FL	GA	HI	IA	IL	IN	KS	KY	MA	MD	MI	MN	MO	MS	MT	NC	NE	NJ	NY	OH	OK	OR	PA	PR	SC	SD	TN	TX	UT	VA	WA	WI	WV    OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam

## Key facts

- **Recall number:** Z-1374-2022
- **Recalling firm:** Ventana Medical Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-20

- **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-1374-2022

## Citation

> AI Analytics. FDA recall Z-1374-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1374-2022. Source: US FDA. Licensed CC0.

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