Events

A-dec 311 Chair and A-dec 361 Support Centre 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 A-DEC Australia 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-00380-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00380-1
  • 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
    The strength of some screws (or "fasteners") may have been compromised due to a plating process issue. under certain circumstances, the fasteners can become brittle, which might lead to a chair and/or delivery system instability.
  • 조치
    The sponsor is advising their customers that the dealer will be replacing the fasteners with screws unaffected by hydrogen embrittlement.

Device

A-dec 311 Chair and A-dec 361 Support Centre
  • 모델명 / 제조번호(시리얼번호)
    A-dec 311 Chair and A-dec 361 Support CentreA-dec 311 ChairARTG Number: 118326A-dec 361 Support CentreARTG Number: 118333 Multiple Serial Numbers (see attached)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA