Medical Intelligence HexaPOD evo RT System 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
    22989
  • 사례 시작날짜
    2018-05-17
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 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
    It has been noted that upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification (e.G. imaging). this description is not relevant for an iguide workflow (6d). the problem occurs only when you switch from a 6d to a 3d workflow without iguide.
  • 조치
    Manufacturer to issue advice regarding use

Device

Manufacturer