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
    15008
  • 사례 시작날짜
    2013-07-17
  • 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
    As issue has been identified in the raystaion 3.0 and 3.5 dose volume statistics calculation. under certain conditions resampling of regions of interest (roi) geometries to the dose grid representations is not correctly calculated and an additional voxel layer is added incorrectly on the superior side of each roi., the problem is pronounced for very small rois, leading to a possible over estimation of the dose maximum or a possible under estimation of the dose minimum, thus always erring on the safe side. worst-case scenario is delivering less dose than optimal to target organs.
  • 조치
    Manufacturer to issue advice regarding use

Device

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

Manufacturer

RaySearch Laboratories AB