Events

ONCENTRA Brachy version 3.x and 4.x 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Nucletron Pty Limited 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-00448-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00448-1
  • 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
    In oncentra brachy (brachy planning (bp) module and plan analysis (pa) module) dose may be incorrectly calculated for regions of interest (rois) defined on a secondary image series when using specific registration methods. the magnitude of the dose calculation error depends on the registration transformation and can vary between 0 and 100% of the correct dose value.
  • 조치
    A software patch is in development to correct this issue and is expected to be released end of November, 2015. Nucletron will work with their customers to implement the patch on affected devices. In the interim, end users are advised to resample Regions of Interest defined on a secondary image series onto the primary image series prior to dose evaluation. This action has been closed-out on 4/08/2016.

Device

ONCENTRA Brachy version 3.x and 4.x

Manufacturer

Nucletron Pty Limited