Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals

Date: 07/22/2021

Product type: Medical Device

Recalled Product

  • Continuous Ventilator, Minimum Ventilatory Support, Facility Use: Philips Respironics E30 with Humidifier
  • Continuous Ventilator, Non-life Supporting devices: DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+, and
  • Noncontinuous Ventilators: SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, and REMstar SE Auto)
  • Product codes: BZD and MNS
  • Manufacturing Dates: April 11, 2007 to April 22, 2021.
  • Distribution Dates: July 21, 2009 to April 22, 2021
  • Date Initiated by Firm: June 14, 2021

US-FDA Link: