Events

iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Trumpf Med Aust 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-00458-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00458-1
  • 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
    Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds of spring arms over time when subject to extreme forces. there is a risk the monitor could fall and swing freely on the swing arm and strike a person or object. there have been no reports of injuries as a result of this issue.
  • 조치
    Trumpf Medical is advising users that if the systems are due for biennial maintenance, to contact the authorised service provider to schedule the preventative maintenance. If the biennial maintenance is not due, and the service provider did not inspect the welds during the previous maintenance, contact the service provider to schedule a service call to inspect the welds. Requirements to inspect the welds during biennial maintenance can be found in the User Manual.

Device

iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Came...
  • 모델명 / 제조번호(시리얼번호)
    iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring Systems All Serial Numbers affectedARTG Numbers: 200921, 200946, 200943, 200945,170219, 170545
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd