FDA Medical Device Recalls (openFDA)
Precision Valve & Automation,Inc: 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.
- Recall number
- Z-2805-2020
- 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.
- Status
- Open, Classified
- Initiated
- 2020-06-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 3 units
- Distribution
- Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
- Lot, serial or model codes
- Lot #: EV123732 Serial #s: L1002, L1005, L1006
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 3001151872
- Firm city
- Cohoes
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28