Devices

Device Recall iLab

  • 모델명 / 제조번호(시리얼번호)
    Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to 13 US consignees and 10 foreign consignees.
  • 제품 설명
    iLab Utrasound Imaging System, software controlled Imaging Catheter.
  • Manufacturer
    Boston Scientific Target
  • 1 Event

제조사

Boston Scientific Target
  • 제조사 주소
    Boston Scientific Target, 4701 Lakeview Blvd, Fremont CA 94537
  • Source
    USFDA