Events

OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ClaveGuard 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-00989-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00989-1
  • 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
    Claveguard ols-500 & ols-700 surgical lights manufactured since january 2015 have potential for the locating pin on the light handle to become detached in the event the restraining grub screw works loose.
  • 조치
    Dickson & Dickson Healthcare are inspecting all affected systems to ensure the correct installation of the locating pin and perform any corrections required. This action has been closed-out on 18/08/2016.

Device

OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since Januar...
  • 모델명 / 제조번호(시리얼번호)
    OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected. ARTG Number: 198978
  • Manufacturer
    ClaveGuard Pty Ltd

Manufacturer

ClaveGuard Pty Ltd
  • Source
    DHTGA