Events

RaySearch RayStation Radiation therapy treatment planning system 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 RaySearch Laboratories AB 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
    18523
  • 사례 시작날짜
    2015-05-14
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • 원인
    When vmat control points are distributed with a wider gantry angle spacing than 4 degrees, the dose calculation will not be accurate. such plans will never be generated by raystation and imported plans with this wide gantry angle spacing will normally not be possible to use for dose calculation in raystation. however, if the imported plan is assigned to a vmat enabled machine model with minimum dose rate = 0.00 mu/min and minimum gantry speed = 0.0 degrees/s, it is possible to calculate dose., , depending on the individual plan, local dose inaccuracy in some regions close to the patient surface may range from under a percent to several percent of dose max. the deviation increases with the gantry angle spacing and with the number of affected control points. the problem will mainly occur in the region furthest away from the isocenter.
  • 조치
    Software to be upgraded

Device

RaySearch RayStation Radiation therapy treatment planning system
  • 모델명 / 제조번호(시리얼번호)
    Model: RayStation, Affected: , Software version: 2.5, 3.0, 3.5, 4.0
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB