Events

Oncentra RTP 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Nucletron BV 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
    21821
  • 사례 시작날짜
    2017-08-17
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • 원인
    The default step size set in rdstore is typically used during the planning process. the measured source paths for a ring-type applicator always have a source step size of 2.5 mm for the microselectron afterloader. when creating an oncentra brachy plan for a ring applicator with a measured source path, the step size of the measured source path will be used for the entire plan., the issue is caused by the measured source paths for the applicators listed below, which have a source step size of 2.5 mm for the microselectron afterloader. if you use such an applicator model to create a plan, while the default step size of the afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. they will be shown as 2.5 mm, while the afterloader will deliver at 5.0 mm if the error is not detected during plan approval.
  • 조치
    Software to be upgraded

Device

Oncentra RTP
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Oncentra Brachy versions 4.5, 4.5.1, 4.5.2.
  • Manufacturer
    Nucletron BV

Manufacturer

Nucletron BV