Events

Arthrex ITD Articulating Arm 300 + 350MM 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-2016-RN-01192-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01192-1
  • 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 manufacturer has identified that the rivets of the rotation on the item ‘vesa 75 / 100 adapter connection with rotation’, which is an integral part of the articulating arm 300 + 350mm, may not have been executed in accordance with the relevant standards. the rivets may be weak. in exceptional cases, the connection panel may become loose or detached when subjected to continuous operation. this may potentially endanger the safety of patients, users or third parties. there have been no reported cases of loss or damage in the field related to this issue.
  • 조치
    Device Technologies is advising users that a repair kit will be provided to all affected customers to correct the device. This action has been closed-out on 18/05/2017.

Device

Arthrex ITD Articulating Arm 300 + 350MM
  • 모델명 / 제조번호(시리얼번호)
    Arthrex ITD Articulating Arm 300 + 350MMProduct Code: AR-5995SAS-FP30Serial Numbers: 001-061736, 001-061740, 001-061742, 001-061745 ARTG Number: 207096
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd