RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 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-2015-RN-00207-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-19
  • 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 issue concerns an error in dynamic multileaf collimator (dmlc) dose calculation for machines where the mlc is positioned above the jaws or the jaws are fixed. the output factor correction is computed from the irradiated area of the first control point but is applied to the entire beam. if the irradiated areas of the remaining control points are significantly different from the initial area, the output factor correction used for these control points will be incorrect.The maximum possible error in dose corresponds to the span of the output factor corrections of the beam model. for example, if the output factor corrections span 0.95-1.05, the maximum theoretical error is 10%, although for most plans, the error would be less.Machines that have backup jaw and the mlc below non-fixed jaws (e.G. varian linacs) and linacs that do not have backup jaw (e.G. siemens linacs and elekta agility) are not affected.
  • 조치
    DMLC dose calculation for the affected linac types will be turned off in patch version 4.7.1 of RayStation, scheduled for market release April 2015. In the meantime, users are advised that if DMLC has been in use for affected linac types, review the beam models. The possible error in dose depends on the span of the output factor corrections. Deprecate any beam models that have been commissioned as DMLC capable for the affected linac types. Does not commission beam models as DMLC capable for the affected linac types.

Device

  • 모델명 / 제조번호(시리얼번호)
    RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy treatment planning system)Software versions affected: 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 and 4.7.0.15ARTG Number: 195288
  • Manufacturer

Manufacturer