Events

Varian C-Series High Energy Linear Accelerator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Varian 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
    16913
  • 사례 시작날짜
    2014-07-04
  • 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
    Varian has received several reports of unexpected beam output variations with the c-series high energy [he] linear accelerator for 6mv photon treatment mode. the issue has been reported for versions 7, 8 and 9 with 6 mv configuration and maximum dose rate of at least 600 mu/min only. it was determined during intensive investigation that the 6mv target had developed a cavity or hole. degradation of the target led to beam output and symmetry changes which were not detected by the linear accelerator. the result is that a lower than intended dose could be delivered to the target volume if treatment were to take place. varian has not received any report of misadministration or injury due to this 6mv target degradation or failure.
  • 조치
    Software to be upgraded

Device

Varian C-Series High Energy Linear Accelerator
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300 C/D, Clinac DHX, Clinac 21EX, Clinac 23EX, Affected: , Software version: Version: 7, 8 and 9 with 6 MV configuration and maximum dose rate of at least 600 MU/min ONLY
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc