Device Recall GE DatexOhmeda Engstrom Carestation

  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of TX and countries of Austria, Bangladesh, Belgium, Costa Rica, Denmark, Finland, France, Germany, India, Italy, Mexico, Saudi Arabia, South Africa, Sweden, Switzerland, United Kingdom, United Arab Emirates.
  • Product Description
    GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA || Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA