CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
bellavista 1000 ventilator recalled by Vyaire Medical
Vyaire Medical is recalling bellavista 1000 ventilator, distributed nationwide in the US. The recall was initiated on 25 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1439-2020
- FDA event ID
- 84337
- Recalling firm
- Vyaire Medical, Mettawa, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2019
- FDA classified
- 4 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 25 Nov 2019 | Recall initiated by company | |
| 4 Mar 2020 | Classified by FDA | +100 days |
| 11 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.
Nationwide AlabamaCaliforniaColoradoFloridaGeorgiaIllinoisMarylandMichiganPennsylvaniaPuerto RicoTexasWashington
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, MD, MI, PA, TX, WA and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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