Cohoes, NY, United States
Precision Valve & Automation,Inc recalls
1 recall recorded since 2018, most recently on 26 June 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 June 2020
- 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.
- Distribution
- Worldwide distribution - US Nationwide including in the state of NY and the country of Rwanda.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2805-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.