RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (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-00182-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-16
  • 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
    A software bug has been reported that when using certain roi (region of interest) editing tools, if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down, the views can appear as if the left mouse button had been released to complete editing. in order for the bug to cause saving of an unintended state, it has to be triggered during the very last edit made to the roi. saving of an unintended state may lead to ineffective and/or unintended radiation therapy. the patient views and the beam’s eye view will always be displayed correctly in the plan approval dialog and in the plan reports. closing and reloading a case will always generate correct views. dose is always computed based on the stored system state.
  • 조치
    This issue will be resolve after the installation of RayStation 5 Service Pack 1, which was released Q1 2016. In the interim, users are advised to: -Always release the left mouse button before using other keys or mouse buttons. -If the warning message “Temporary items should not be visible on approval” is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. This action has been closed-out on 06/02/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)Software build number : 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4ARTG Number: 195288
  • Manufacturer

Manufacturer