Events

Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia Pty Ltd 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
    RC-2013-RN-01053-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01053-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Device technologies australia (dta) in conjunction with the manufacturer is informing users of an important change in the instructions for use (ifu) for the reliance endoscope processing system (eps) when processing specific fujinon g5 and g8 type flexible gi endoscopes. when set up as defined in the ifu the air pipe on specific fujinon endoscopes doesn’t receive forced flow during the processing cycle. a new steris flow unit 7 has been developed to facilitate forced flow of high level disinfecting solution through the air pipe and is required for reliance eps processing of any impacted fujinon devices. a new “quick reference guide” has been developed to incorporate these changes.
  • 조치
    Device Technologies is providing their customers with a new “Quick Reference Guide” and requesting that reprocessing G5 and G8 type endoscopes is discontinued until the correct flow unit #7 is provided.

Device

Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes
  • 모델명 / 제조번호(시리얼번호)
    Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI EndoscopesMultiple FUJINON G5 and G8 Type Flexible GI Endoscope series affectedARTG Number: 112590
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd