Events

Varian VariSource TM iX Console software with magnetic hard disk drive only 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Varian Medical Systems Haan 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
    18584
  • 사례 시작날짜
    2015-05-28
  • 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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
  • 원인
    Varisource ix console software version 1.2, build 2.4336 will occasionally freeze during the treatment initiation sequence. an application freeze is a condition when, after pressing the deliver treatment button the the treatment delivery strip, the treatment delivery strip becomes blank and the afterloader remains in idle mode and does not switch to treatment delivery mode. no other buttons on the control software user interface will respond. as a consequence of a system freeze there is the potential for the partial fraction generated by the system to be incorrect.
  • 조치
    Software to be upgraded

Device

Varian VariSource TM iX Console software with magnetic hard disk drive only

Manufacturer

Varian Medical Systems Haan GmbH