Events

ED-530TK Duodenoscope 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fujifilm 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-2018-RN-00146-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00146-1
  • 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
    In response to recent concerns regarding the ability to thoroughly clean duodenoscopes, fujifilm has redesigned some components of the ed-530xt duodenoscope. corrective actions for the ed-530xt include replacement of the forceps elevator mechanism and o-ring seal, replacement of the distal end cap, and new operation manual. the updated design, maintenance schedule and labelling have all been implemented to help reduce any potential risk to health that may be associated with inadequate reprocessing of the device.Fujifilm, through the distributor c.R. kennedy & co, will provide a revised operation manual to be followed. below is the main update to the operation manual:- added the requirement for the ed-530xt to be returned to local fujifilm dealer or authorised service representative for inspection and replacement of the forceps elevator seal once a year to maintain safe use of the device.
  • 조치
    FujiFilm is advising users to review and update the handling and re-processing procedures. Affected products will be serviced to replace the affected parts.

Device

ED-530TK Duodenoscope
  • 모델명 / 제조번호(시리얼번호)
    ED-530TK DuodenoscopeSerial Numbers: MD102A129, MD102A130, 1D102K227, 1D102K388, 1D102K394, 1D102K436, 1D102K460, D102K508, 1D102K517ARTG Number: 139172(Fujifilm Australia - Duodenoscope, flexible, video - Dudoenoscope, flexible, video)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd