Device Recall Evita XL Continuous Ventilator

  • Model / Serial
    Catalog number 8414900. 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Evita XL Critical Care Ventilator. Continuous (Respirator)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
  • Source
    USFDA