Device Recall Maquet CARDIOSAVE

  • 모델명 / 제조번호(시리얼번호)
    0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55.   CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide distribution
  • 제품 설명
    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
  • 제조사 모회사 (2017)
  • Source
    USFDA