Events

Dameca Anaesthesia systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Dameca A/S 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
    18175
  • 사례 시작날짜
    2015-03-06
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function. it can be brought up to working condition again by simply pulling it out. the control dial is part of the user interface and serves an important role in setting and controlling the anaesthesia machine functions as it is used to adjust and confirm settings made by the user., for siesta i breasy, siesta i whispa and mri 508 freshgas regulation and ventilator mode change (manual or ventilator) can still be done as this is mechanical and/or soft key controlled and doesn't need confirmation by the control dial.
  • 조치
    Product to be modified

Device

Dameca Anaesthesia systems
  • 모델명 / 제조번호(시리얼번호)
    Model: IntelliSave AX700 (866205/10623-00), Dameca MRI508 (866203/10651MRI-00), Siesta iWhispa (866202/10651-00), Siesta iTS (866163/10653-00), Siesta Breasy (866204/10652-00), Affected: Multiple serial numbers affected
  • Manufacturer
    Dameca A/S

Manufacturer

Dameca A/S