Events

MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-2017-RN-01394-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01394-1
  • 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
    It has been concluded that there is a low failure rate that only can present itself on the devices of types and production identified in this letter. the issue relates to a crack in the metal of the spring arms that has the potential develop into a break. this potential for malfunction is caused by fissures near the weld seam at the front pivot of the spring arm. the design of the spring arm was improved in 2006. the devices are over ten years old and even so the vast majority have not failed. there have been related complaints, however to date no events involving injury have been reported.
  • 조치
    Getinge is advising users that all potentially affected spring arms will be replaced with new spring arms.

Device

MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL ...
  • 모델명 / 제조번호(시리얼번호)
    MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)Multiple part numbers affectedARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd