Devices

Device Recall Evita 4 Continuous Ventilator

  • Modèle / numéro de série
    Catalog numbers 4116640 and 8412980
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.
  • Description du dispositif
    Evita 4 Continuous Ventilator
  • Manufacturer
    Draeger Medical, Inc.
  • 1 Event

Fabricant

Draeger Medical, Inc.
  • Adresse du fabricant
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969
  • Source
    USFDA

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Device Recall Evita 4 Continuous Ventilator
  • Modèle / numéro de série
    Catalog number 8411900. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part number 8306611 replaced between January 2005 and May 2008. The serial number for the affected CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
  • Description du dispositif
    Evita 4 Critical Care Ventilator. Continuous (Respirator)
  • Manufacturer
    Draeger Medical, Inc.