Events

Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems 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-2018-RN-00120-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00120-1
  • 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, getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. the observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. only one (i.E. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery.
  • 조치
    Getinge is advising users that a service technician will be correcting all affected units.

Device

Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems
  • 모델명 / 제조번호(시리얼번호)
    Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting SystemsManufactured between August 2009 and July 2014Multiple Part Numbers affected ARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd