Events

Device Recall Evis Exera II Duodenovideoscope Olympus TJFQ180V 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
    73059
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0757-2016
  • 사례 시작날짜
    2016-01-08
  • 사례 출판 날짜
    2016-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142937
  • 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
    duodenoscope and accessories, flexible/rigid - Product Code FDT
  • 원인
    Olympus america inc is conducting a voluntary removal/corrective action of all tjf-q180v duodenoscopes in order to replace the forceps elevator mechanism olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared tjf-q180v 510k.
  • 조치
    Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688.

Device

Device Recall Evis Exera II Duodenovideoscope Olympus TJFQ180V
  • 모델명 / 제조번호(시리얼번호)
    all codes
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution except PR
  • 제품 설명
    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope || Product Usage: || This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
  • Manufacturer
    Olympus Corporation of the Americas

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