Events

Maquet H LED and PowerLED 700 Ambient Light Modules 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Maquet SA 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
    16434
  • 사례 시작날짜
    2014-04-02
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • 원인
    The ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. in some product models, this module is attached to the cupola through a set of 4 fixing tabs, which compose the plastic enclosure of the ambient light module. there is a potential risk of failure concerning the fixation of the module. it has been observed by some of our customers that one or several fixing tabs were broken, which led the ambient light 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
    Product to be modified

Device

Maquet H LED and PowerLED 700 Ambient Light Modules
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: HLED700, PWD700, Affected: All units manufactured between Dec-2006 and Dec-2012
  • Manufacturer
    Maquet SA

Manufacturer

Maquet SA