Device Recall Gas Delivery Engine

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
  • Product Description
    Gas Delivery Engine (GDE)-refurbished, R16650A || A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
  • Manufacturer
  • 3 Events

Manufacturer

  • Manufacturer Address
    Carefusion 211 Inc dba Carefusion, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source
    USFDA