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
MB170104MB170118MB170151MB170202MB230000MB230020MB230024MB230027MB230031MB230033MB230035MB230036MB230037MB230038MB230039MB230040MB230041MB230046MB230048MB230049MB230052MB230053MB230054MB230055MB230056MB230057MB230058MB230059MB230060MB230061MB230062MB230063MB230064MB230065MB230066MB230067MB230068MB230069MB230070MB230071MB230072MB230073MB230074MB230075MB230076MB230077MB230078MB230079MB230080MB230081MB230082MB230083MB230084MB230085MB230086MB230087MB230088MB230089MB230090MB230091
- Serial numbers
- 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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