Recall Z-1439-2020— Vyaire Medical

Name: FDA recall Z-1439-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-25

Class II · Terminated

Class II FDA medical device recall by Vyaire Medical, initiated 2019-11-25, terminated 2023-08-08. It names one FDA 510(k) clearance: K163127. 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.. Reason: 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..

Recalling firm: Vyaire Medical
Classification: Class II
Status: Terminated
Initiated: 2019-11-25
Terminated: 2023-08-08
Firm location: Mettawa, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K163127 — bellavista 1000Imtmedical AG·cleared 2017-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.