Device Recall Dudenoscope

  • 모델명 / 제조번호(시리얼번호)
    Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107  Model Number: ED-200XT: Serial Number: 8681034  Model Number: ED-250XT: Serial Number: HD077A008  Model Number: ED-310XU: Serial Number: 8591013  Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026  Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022  Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100  Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020  Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
  • 제품 설명
    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
  • 제조사 모회사 (2017)
  • Source
    USFDA