Reported Feb 23, 2022 · Terminated
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista…
Vyaire Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
- Lot codes and dates
- Hardware generation G6, software version V6.0.1600.0 or higher installed, all serial numbers. UDI 07640149381115 (bellavista 1000 ventilator) and 07640149388879 (bellavista 1000e ventilator).
- Amount recalled
- 4189 units
Where it was sold
Why it was recalled
Stop using this product now
Potential cessation in ventilation can occur under specific conditions.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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