Events

Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 American Medical Systems 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-2015-RN-00570-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00570-1
  • 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
    American medical systems (ams) has determined that the validation data related to cleaning instructions and sterilisation methods and the methods defined in instructions for use (ifu) do not meet the new guidance on qualifying reusable products.
  • 조치
    AMS is requesting the return of all unused inventory in the field. If the inventory has been used, and has not been discarded, AMS is requesting that the customers discard the devices or return the used device to AMS directly. AMS will be extending a credit to the customers for the purchase price.

Device

Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers
  • 모델명 / 제조번호(시리얼번호)
    Reusable Stripper and Cleaver Accessories used with Sureflex and Aura Laser Fibers Multiple model numbersARTG Numbers: 145536 &169227
  • Manufacturer
    American Medical Systems Australia Pty Ltd

Manufacturer

American Medical Systems Australia Pty Ltd
  • Source
    DHTGA