Events

RaySearch 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
    20610
  • 사례 시작날짜
    2016-09-06
  • 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
    Two issues have been identified with the dose calculation when using a region of interest (roi) of type fixation or support with material override within the patient outline in raystation models., 1. when an roi with material override overlaps a fixation or support roi, the material used for dose calculation in the overlapping region may not be as intended., 2. when a support or fixation roi overlaps the patient outline (external roi) in a dose grid voxel along the outer surface of the patient outline, the density used for dose calculation in that voxel may not be as intended.
  • 조치
    Instructions for use to be updated

Device

RaySearch Radiation Therapy Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    Model: 2.5, 3.0, 4.0, 4,5, 5.0 and 4.3 and InverseArc 1.0, Affected:
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB