Vyaire Medical: Medical Device Recall in 2020 - (Recall #: Z-1439-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 25, 2019

Date Posted: March 11, 2020

Recall Number: Z-1439-2020

Event ID: 84337

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.

Status: Terminated

Product Quantity: 116

Code Information:

Serial numbers: MB170104, MB170118, MB170151, MB170202, MB230000, MB230020, MB230024, MB230027, MB230031, MB230033, MB230035, MB230036, MB230037, MB230038, MB230039, MB230040, MB230041, MB230046, MB230048, MB230049, MB230052, MB230053, MB230054, MB230055, MB230056, MB230057, MB230058, MB230059, MB230060, MB230061, MB230062, MB230063, MB230064, MB230065, MB230066, MB230067, MB230068, MB230069, MB230070, MB230071, MB230072, MB230073, MB230074, MB230075, MB230076, MB230077, MB230078, MB230079, MB230080, MB230081, MB230082, MB230083, MB230084, MB230085, MB230086, MB230087, MB230088, MB230089, MB230090, MB230091, MB230092, MB230093, MB230094, MB230095, MB230097, MB230098, MB230099, MB230100, MB230101, MB230102, MB230104, MB230190, MB230191, MB230194, MB230195, MB230196, MB230197, MB230201, MB230204, MB230205, MB230207, MB230209, MB230210, MB230217, MB230219, MB230220, MB230221, MB230222, MB230227, MB230228, MB230229, MB230230, MB230231, MB230232, MB230233, MB230243, MB230244, MB230246, MB230247, MB230249, MB230251, MB230253, MB230256, MB230258, MB230260, MB230261, MB230262, MB230263, MB230266, MB230270, MB230274, MB230275, MB230277, MB230294, MB230297, MB230298.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated