Events

Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1(Radiology Picture archiving and communication system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia 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-2016-RN-00226-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00226-1
  • 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
    It has been identified that under rare circumstances, imported images and/or studies may re-use a non-unique image directory.This issue may cause incorrect images to be displayed for a patient. it is possible that clinical decisions will be made using an incorrect set of images. if undetected, in the worst case this may result in inappropriate care leading to potential patient harm.
  • 조치
    The sponsor DTA will contact the affected customers and arrange for the implementation of a software upgrade which will resolve the reported issue.

Device

Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiol...
  • 모델명 / 제조번호(시리얼번호)
    Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1(Radiology Picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd