Events

RayStation and RayPlan 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-2018-RN-00128-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-02-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00128-1
  • 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 identified that when more than one beam is defined on the same isocenter, the center beam in field (cbf) affects all beams in a way that the user may not expect.After using cbf, the resulting fields are clearly displayed in raystation/rayplan for review and approval. however, one mistreatment incident using the cbf functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.
  • 조치
    Emergo will be contacting users to update to the next version of RayStation/RayPlan. In the interim, users are advised: · Be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended. · Do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam.

Device

RayStation and RayPlan
  • 모델명 / 제조번호(시리얼번호)
    RayStation and RayPlanModel Numbers: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) andRayStation 7 (RayPlan 7)Serial Numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or7.0.0.19ARTG Number: 195288(Emergo Asia Pacific Emergo Australia - Radiation therapy treatment planning system)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia