Events

Elekta Monaco Radiation Treatment Planning System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Elekta 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
    19289
  • 사례 시작날짜
    2015-10-21
  • 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
    Two identified issues:, 1- in version 5.10.01, the isodose control 100% isodose value was linked to the dose normalization value so users would always have a known normalization value linked to 100% when in relative mode. this however limits the user to only one defined value available above 100%. when the 100% isodose value is edited on the isodose control, the dose normalization is automatically updated. if the user does not notice this update and then rescales to a relative isoline and does not read the dose normalization value displayed on the rescale bar, the rescale could be other than intended., , 2-when the user optimizes, then changes the bolus assignment of the beams, and then selects "calculate" (not "optimize" again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect for the bolus assignment of the beams.
  • 조치
    Software to be upgraded

Device

Elekta Monaco Radiation Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: , Software version: 5.10 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc