FDA Device recall Z-2805-2020
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure
- FDA Device
- Class II
- ongoing
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure by Precision Valve And Automation, citing 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 al….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2805-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-06-26 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Precision Valve And Automation |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot #: EV123732 Serial #s: L1002, L1005, L1006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2805-2020%22
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