Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1439-2020

November 25, 2019

Class II

Product summary

Firm
Vyaire Medical
Event
Event 84337
Status
Terminated
Classification
Class II
Quantity
116
Official record key
device-enforcement:Z-1439-2020

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.