Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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.

FDA Recall Z-2805-2020 · Posted None

Recalling FirmPrecision Valve & Automation,Inc
Recall StatusOpen, Classified
Product CodeBTL
Date Initiated2020-06-26
Product Quantity3 units

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.

Firm Action

Customers will be e-mailed initial recall notice, followed by written letter. Customers will be directed to ship recalled PreVENT back to PVA as soon as possible. Recalled unit will be shipped back to PVA in the same packaging from replacement unit. Recalled units will be scrapped at PVA.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑