RaySearch RayStation 5 (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-2016-RN-01364-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-17
  • 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
    An issue has been identified with the display of dose computed on images other than the planning ct (auxiliary ct) when using multiple patient cases in raystation 5. if a ct image set with the same frame of reference (for) as the displayed auxiliary ct set exists in another case, the dose display may be incorrect. the issue occurs when a plan in one case is used to compute dose on another image set, and when that image set has the same for as an image set in another case. this happens when using the function “compute dose on other data set” in the plan evaluation module or when computing fraction doses in the dose tracking module. the visual display of dose in the patient views can be incorrect and can be shifted and/or rotated. the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. the dose value normally displayed in the upper left corner when pointing in the 2d view may be incorrect or missing.
  • 조치
    The issue will be resolved in the next version of RayStation, scheduled for market release December 2016. Until a corrected version has been installed, all affected users must maintain awareness of the issues. Specifically, be aware that when a patient has multiple cases, the following may be incorrect if there are image sets that share the same Frame of Reference residing in different cases: - Display of evaluation dose computed on another CT image set - Dose tracking fraction dose and deformed dose. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect.

Device

  • 모델명 / 제조번호(시리얼번호)
    RaySearch RayStation 5 (Radiation therapy treatment planning system)Software build number: 5.0.0.37, 5.0.1.11, 5.0.2.35ARTG Number: 195288
  • Manufacturer

Manufacturer