# FDA recall Z-2805-2020

> **Precision Valve & Automation,Inc** · Class II · device recall initiated 2020-06-26.

## Product

PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

## Reason for recall

While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.

## Distribution

Worldwide distribution - US Nationwide including in the state of  NY and the country of Rwanda.

## Key facts

- **Recall number:** Z-2805-2020
- **Recalling firm:** Precision Valve & Automation,Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-26
- **Report date:** 2020-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cohoes, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2805-2020

## Citation

> AI Analytics. FDA recall Z-2805-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2805-2020. Source: US FDA. Licensed CC0.

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