Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Version 11 with PBC 11.0.21, 11.0.30 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Varian Medical Systems Australasia 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-00105-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-02-04
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The final calculated dose of dose dynamic fields will be incorrect when both conditions occur:1. the pencil beam convolution [pbc] 11 algorithm license feature is used,2. either the energy and/or the treatment unit of a dose dynamic field, differs fromthat of the first created treatment field in the plan.Under these conditions, the final dose calculation will determine the mu to dose calibration (mugy10) factor and the applicable dose rate table value (csbf coefficient) using the energy of the first treatment field (in the order of creation) for all dose dynamic fields, regardless of the actual field energy.
  • 조치
    Varian Medical Systems is requesting users to not use the Pencil Beam Convolution (PBC) 11 algorithm for dose dynamic plans. It is recommended that dynamic MLC plans are calculated with the AAA or Acuros XB algorithm. PBC versions prior to version 11 can still be used. Varian recommends a review of treated patient plans where the PBC 11 algorithm was used for the calculation of dose dynamic plans. A technical correction is under development and will be implemented once complete.

Device

  • 모델명 / 제조번호(시리얼번호)
    Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Version 11 with PBC 11.0.21, 11.0.30Product Code: H48ARTG Number: 119983
  • 의료기기 분류등급
  • Manufacturer

Manufacturer