Events

iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Brainlab Australia Pty Ltd 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
    RC-2013-RN-00339-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00339-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Iplan rt dose version 4.0 and 4.1 might not correctly refresh the dose calculation after certain mlc shape modifications if all of the following conditions are met:- the modifications are performed for a dynamic conformal arc, and- the jaw positions are defined manually, and- the dose display (e.G. isodose lines) is turned on, or if the dose has already been calculated and the dose display is turned on again after the mlc shape was modified. the effect may occur for the following modifications of the mlc shape: - the mlc margin of the arc is modified- the mlc shape is modified in the beam’s eye view (bev) in a way that also changes the mlc shapes of neighbouring segments of the arc1- the leaf adaption is modified (inline/average/outline)- the modified mlc shapes in the bev are resetthe dose calculation is not refreshed in the physician’s review and physicist’s verification tasks or when generating the printout or exporting the plan.
  • 조치
    Brainlab is providing work around instructions and is developing a software update to permanently correct the problem.

Device

iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planni...
  • 모델명 / 제조번호(시리얼번호)
    iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system)ARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd