MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Elekta Pty Ltd 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
    RC-2014-RN-00560-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    When using mosaiq 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
    Users are advised that the problem can be avoided by moving the mouse pointer away from the Direction or Site dropdowns or by making sure these options are not selected when using the thumbwheel or touchpad scroll bar. This problem will be resolved in a future MOSAIQ software release. This action has been closed-out on 11/04/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 206321
  • 의료기기 분류등급
  • Manufacturer

Manufacturer