Device Recall Evita XL Continuous Ventilator

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Evita XL Critical Care Ventilator. Continuous (Respirator)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
  • Source
    USFDA