Events

Focal Release 4.80.00 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Elekta Pty Ltd 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-2014-RN-01356-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01356-1
  • 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
    When a ct phantom is scanned and the images are transferred to focal, it is possible to sample the densities using the image statistics tool in focal. in the case where ct slice thickness is not the same as ct slice spacing the image statistics tool will report an incorrect hu. if the user bases their ct to ed file on this incorrect density information, dose calculation errors will result. the magnitude of the dose calculation error will be dependent on the magnitude of the hu error.This problem can only occur for sites who satisfy all of the below criteria:1. running focal release 4.80.00 2. using a ct slice spacing not equal to the ct slice thickness, and3. using the image statistics tool to quantify ct phantom densities which are then used to populate the ct to ed file.There have been no patient injuries reported.
  • 조치
    As an immediate workaround:- The problem can be avoided by using a CT Slice Spacing equal to the CT Slice Thickness; and A software fix will be provided to rectify the defect as soon as possible. This action has been closed-out on 28/02/2018.

Device

Focal Release 4.80.00
  • 모델명 / 제조번호(시리얼번호)
    Focal Release 4.80.00 ARTG Number: 186853
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd