Events

RaySearch Raystation 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 RaySearch Laboratories AB 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
    19767
  • 사례 시작날짜
    2016-02-15
  • 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: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • 원인
    This notice concerns an issue found with some of the tools used for drawing in and interacting with the patient views and beam's eye views. the issue concerns all tools that are used with the left mouse button held down. these tools can become unsynchronized with the stored data if other commands such as for example a right mouse click are used at the same time as the left mouse button is held down., actions to be taken:, 1. always release the left mouse button before using other keys or mouse buttons ., 2. if the warning message "temporary items should not be visible on approval¨ is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the plan approval dialog, or close and reload the patient case and review the structures again.
  • 조치
    Software to be upgraded

Device

RaySearch Raystation

Manufacturer

RaySearch Laboratories AB