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Vyaire Medical recalls bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilatio
Recalled March 11, 2020 · FDA recall Z-1439-2020 · Vyaire Medical
Hazard
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. · FDA Class II
Units
116
Sold at
US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.
Description
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.
Product
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.
Manufacturer(s)
Vyaire Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →