Recall Z-2805-2020 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
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 monito
| Date | Jun 26, 2020 |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.