Vyaire Medical recalls bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilatio…

Recall date

November 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1439-2020

FDA classification

Class II

Brand / firm

Vyaire Medical

Sold / distributed

US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.

Why it was recalled

The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve.