iPlan RT, iPlan RT Dose and BrainSCANAll Software versions 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-2016-RN-01641-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-12-23
  • 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
    Brainlab has identified an issue where there is the possibility of a potential inaccurate dose calculation for small mlc-shaped fields when using the pencil beam algorithm. the pencil beam algorithm refers to beam data which is acquired by performing dose measurements for mlc fields at predefined field sizes and which are stored using the iplan rt physics administration / brainscan beam profile editor. due to an inaccurate implementation in the brainlab radiation treatment planning software, the interpolation between two measured values is less accurate a) the smaller the field and;b) the further away the equivalent field size is from the measured value. for certain treatment setups, this leads to the effect that an insufficient amount of monitor units (mu) is calculated and that consequently the delivered dose is lower than the planned dose. for clarity, the delivered dose does not exceed the planned dose due to the described issue.
  • 조치
    As a workaround, to reduce the described dose deviation to less than 2% using the Pencil Beam algorithm in iPlan RT 4.5.x Brainlab recommends to modify the machine profile following the instructions outlined in the Appendix provided. For all Brainlab treatment planning systems, as recommended by Brainlab, perform proper pre-treatment quality assurance for every treatment plan. Independent calculation of the dose using 3rd party QA Software or dose measurements inside a phantom is suitable to judge the accuracy of the dose calculation. Refer to the Brainlab Physics Technical Reference Guide for details.

Device

  • 모델명 / 제조번호(시리얼번호)
    iPlan RT, iPlan RT Dose and BrainSCANAll Software versionsARTG Number: 121114
  • Manufacturer

Manufacturer