It’s High-Risk Class I For Vyaire’s Recall Of Bellavista Ventilators

17 Feb 2022

• By Shawn M. Schmitt

The US FDA on 17 February labeled a recall of 2,605 Bellavista 1000 and 1000e series ventilators as class I. Vyaire Medical Inc. had recalled the vents in late December.

Recall Road Sign against sky. — • Source: Shutterstock

Vyaire Medical Inc. has recalled 2,605 Bellavista 1000 and 1000e series ventilators because of software troubles. The US Food and Drug Administration gave the recall action a high-risk class I designation on 17 February.

The FDA says it has received reports of ventilators “failing to ventilate and generating a technical failure alarm.”