PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2015-RN-00050-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-19
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Maquet received complaints of grinding on double (2 arms) or triple suspensions (3 arms), with paint possibly chipping from the junction between the 2 arms.Paint chips or particles can fall down from the suspended lights. this may happen during surgical procedures, in which case, paint chips may fall inside the surgical field of a patient.
  • 조치
    A Maquet technical specialist will arrange to inspect all potentially affected devices. Where grinding arms are detected a replacement of the suspension will be provided. This action has been closed-out on 05/09/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling SuspensionUnits manufactured between March 2012 and July 2014ARTG Number: 162037
  • Manufacturer

Manufacturer