Reported Mar 11, 2020 · Terminated

bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic…

Vyaire Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vyaire Medical · 26125 N Riverwoods Blvd · Mettawa, IL · 60045-3420

Is this the product you have?

  • 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.
Lot codes and dates
  • Serial numbers

    116 of 116 codes

    • 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
Amount recalled
116

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 8, 2023 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.