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Recall Alert: Vyaire Medical bellavista™ 1000 and 1000e Series Ventilators

Wednesday, March 16, 2022

Due to issues with specific software versions and configurations, Vyaire Medical has recalled its bellavista 1000 and 1000e Series Ventilators. The use of affected ventilators may cause the ventilator to malfunction or stop. The FDA has identified this as a Class 1 recall, as use of affected devices may cause serious injuries or death. 

  • Recalled product names: Vyaire Medical bellavista 1000 and 1000e Series Ventilators
  • Distribution dates: Jan. 26, 2017–Dec. 23, 2021
  • Devices recalled in the U.S.: 2,605

Visit the FDA’s recall page at https://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-recalls-bellavista-1000-and-1000e-series-ventilators-due-issues-software for additional details, contact information and resources.

We encourage providers to notify patients affected by this recall.