Events

RayStation 3.0, 3.5, or 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-2013-RN-01103-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01103-1
  • 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
    A dose calculation error has been identified in raystation versions 3.0. 3.5, and 4.0, when elekta motorised wedges are used for a beam and the wedge angle differs from 60 degrees. the error is that the modified energy spectrum has been used not only for the wedged part of the beam but also for the open part of the wedged field. for all clinical cases investigated by the manufacturer, the deviations were at the most 3-5% in the clinically relevant areas of the plan. deviations in the 10-12% range may occur in the buildup regions where dose calculations are generally considered approximate.
  • 조치
    The issue will be resolved in RayStation patch 4.0.2 scheduled for market release in December 2013 and in all future releases. In the interim, workarounds for creating a beam with Elekta motorized wedge, without and with wedge optimization in described in the customer letter.

Device

RayStation 3.0, 3.5, or 4.0 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia