RayStation 3.5 and 4.0 (Radiation therapy treatment planning system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-2014-RN-00173-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-24
  • 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 manufacturer has become aware of an issue found with the dose calculation in raystation 3.5 and 4.0. the error appears in some situations for bolus/external/fixation/support structures that are outside the image stack but covered by the dose grid. when converted to dose grid structures, they are cut off at the image stack boundaries (first and last slice) in the inferior-superior direction. for a bolus/external/fixation/support structure this means that the part outside the image stack does not contribute to the density distribution and the dose calculation will be affected and may result in under dosing.
  • 조치
    Emergo is advising users to avoid the creation of treatment plans where the beam passes through a support or a fixation which is not imaged and where the support or fixation is placed on the superior or inferior side of the CT stack. Emergo is recommending the external ROI is not extended past the CT stack in the inferior or superior direction. If a bolus is used for the superior or inferior beams, users are advised to image enough slices above the patient head to fit the bolus inside the CT stack. Emergo is recommending users do not use dose tracking with oblique beams entering through the superior or inferior CBCT slice. A software patch will be installed on all affected users to correct the issue.

Device

Manufacturer