Events

Device Recall EVIS EXERA Duodenovideoscopes OLYMPUS JF140F 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Olympus Corporation of the Americas 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79998
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2269-2018
  • 사례 시작날짜
    2018-05-11
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164185
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology - Product Code FET
  • 원인
    Issuance of validated, new reprocessing procedures. this corrective action is being undertaken as a result of ongoing manufacturer and fda activities relating to reported patient infections associated with duodenoscopes. the new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
  • 조치
    Firm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business

Device

Device Recall EVIS EXERA Duodenovideoscopes OLYMPUS JF140F

Manufacturer

Olympus Corporation of the Americas
  • 제조사 주소
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA