Events

Elekta MOSAIQ with Evaluate 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Impac Medical Systems Inc 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
    16720
  • 사례 시작날짜
    2014-05-19
  • 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
    When using couch move assistant (cma), if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse pointer to a different area of the screen. likewise, if the user hovers the mouse pointer exactly above the site dropdown and uses the mouse thumbwheel or touchpad scroll bar, the site could change and the direction and offset will change depending on the site selected. an inadvertent change can also occur if either the direction or site dropdown is selected, the mouse pointer is anywhere on the dialog, and the mouse thumbwheel or touchpad scroll bar is used.
  • 조치
    Software to be upgraded

Device

Elekta MOSAIQ with Evaluate
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: , Software version: Versions 1.40 through 2.50, inclusive
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc