FDA: Class I recall of Vyaire Medical’s Bellavista Ventilators

Editor's Note

The Food and Drug Administration (FDA) on February 17 identified the recall by Vyaire Medical (Mettawa, Illinois) of its Bellavista 1000 and 1000e Series Ventilators as Class I, the most serious.

The recall was initiated because of issues with the software version 6.0.1600.0 or higher, after reports of ventilators failing to ventilate and generating a technical failure alarm. The use of affected ventilators may cause serious adverse events or death.

To date there have been 18 complaints, 7 injuries, and no deaths.

The ventilators were distributed between January 26, 2017 and December 23, 2021.