Events

Varian Clinac, Trilogy, Trilogy Tx, Novalis Tx, and Unique Accelerators 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
    15626
  • 사례 시작날짜
    2013-11-06
  • 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
    Events have been reported in which a user has remotely rotated the gantry into contact with the couch or with patients, in both the manual mode and the automated mode. in one event, a patient was reported injured when the user operating the gantry in manual mode, rotated the gantry of a clinac® 21ex into physical contact with the patient's pelvis. this event involved use of remote manual control of gantry rotation (i.E. controlled manually from outside the treatment vault). such a motion is not a preprogrammed motion and is exclusively under the control of the operator.
  • 조치
    Software to be upgraded

Device

Varian Clinac, Trilogy, Trilogy Tx, Novalis Tx, and Unique Accelerators
  • 모델명 / 제조번호(시리얼번호)
    Model: Product Codes: H14, H18, H27, H29, Affected: Versions: 7.x, 8.x, 9.0
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc