Events

H LED and PowerLED Ambient Light Modules (Surgical light) 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-2014-RN-00347-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00347-1
  • 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
    There is a potential risk of failure concerning the fixation of the ambient light module. it has been observed by some of the customers that one or several fixing tabs were broken, which led the module to detach, remaining attached by its wires only. the occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.
  • 조치
    All customers are asked to check if the ambient light module is correctly fixed. The procedure for this is provided with the customer letter. If any issues are detected by the customer, precautions should be taken in order to avoid the component falling and a Maquet representative should be contacted immediately in order to replace the broken ambient light module with a new one.

Device

H LED and PowerLED Ambient Light Modules (Surgical light)
  • 모델명 / 제조번호(시리얼번호)
    H LED and PowerLED Ambient Light Modules (Surgical light)Model numbers: PWD700 and H LED 700 All lots manufactured from December 2006 to December 2012ARTG Number: 162037
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd