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.
Check against the official notice below — it lists the full affected range.
Vyaire Medical is recalling 4,189 units of the bellavista 1000 and bellavista 1000e ventilators due to a potential cessation in ventilation that can occur under specific conditions. The affected devices include all units with hardware generation G6 and software version V6.0.1600.0 or higher. These ventilators were distributed worldwide, including throughout numerous U.S. states and territories, as well as internationally in countries such as Canada, Australia, Brazil, and many others.
The source document does not specify a remedy or instructions for affected consumers regarding what actions they should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential cessation in ventilation can occur under specific conditions.
Reason for recall: Potential cessation in ventilation can occur under specific conditions. 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 Repu Quantity: 4189 units Lot/code info: 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).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.