Events

Eschman RX Powered Operating Tables 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Eschmann Holdings Ltd t/a Eschmann Equipment 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
    16353
  • 사례 시작날짜
    2014-03-13
  • 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: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • 원인
    Following a reported incident it has been identified that handsets are being disassembled by users, presumably to facilitate a repair., the disassembly of the handset for any reason can compromise the seal that protects the internal circuits from fluid ingress. should fluid enter the handset; this can cause an unrequested movement of the operating table top.
  • 조치
    Manufacturer to issue advice regarding use

Device

Eschman RX Powered Operating Tables

Manufacturer

Eschmann Holdings Ltd t/a Eschmann Equipment