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.
Reported: February 23, 2022 Initiated: December 20, 2021 #Z-0622-2022
Product Description
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.
Reason for Recall
Potential cessation in ventilation can occur under specific conditions.
Details
- Recalling Firm
- Vyaire Medical
- Units Affected
- 4189 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI and WV, including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, France, Germany, Guatemala, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Namibia, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.
- Location
- Mettawa, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Vyaire Medical. Units affected: 4189 units.
Why was this product recalled? ▼
Potential cessation in ventilation can occur under specific conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 23, 2022. Severity: Critical. Recall number: Z-0622-2022.
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