Z-2805-2020Class II

PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19...

Name: Z-2805-2020 PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19...
Creator: Precision Valve & Automation,Inc
Published: 2020-06-26
License: https://open.fda.gov/license/

Precision Valve & Automation,Inc / initiated 2020-06-26 / Open, Classified / root cause: software

FDA source

Precision Valve & Automation,Inc began a recall of PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device... on 2020-06-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2805-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-26
Posted: 2020-08-14
Recalling firm: Precision Valve & Automation,Inc
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.
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 3 units
Distribution: Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
Product codes and lots: Lot #: EV123732 Serial #s: L1002, L1005, L1006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2805-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2805-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-14

Product code BTL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)