Events

Elekta HexaPOD evo RT System, iGUIDE 2.0 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medical Intelligence Medizintechnik GmbH 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
    16780
  • 사례 시작날짜
    2014-06-05
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • 원인
    The iguide key allows you to treat patients without using the hexapod evo rt system. when you turn the iguide key to the off position:, · the external inhibit signal is overridden., · the iguide software closes any open fractions and logs off (login appears)., in some circumstances, a bug in the iguide software prevents the iguide software from logging off. the iguide software looks like it can be used for positioning, but it is no longer running correctly. even when you turn the iguide key back to the on position, it will not set the external inhibit signal or alert you if the position has changed (position guard is inactive).
  • 조치
    Software to be upgraded

Device

Elekta HexaPOD evo RT System, iGUIDE 2.0

Manufacturer

Medical Intelligence Medizintechnik GmbH