Precision Valve & Automation,Inc recalls PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory f…

Recall date

June 26, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2805-2020

FDA classification

Class II

Brand / firm

Precision Valve & Automation,Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.