Events

Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 12.0 (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-2014-RN-00689-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00689-1
  • 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
    Mckesson has identified a rare software issue when two or more processes attempt to modify the same image folder within fractions of a second, the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in loss of data within the image folder. as both simultaneous write access and lock mechanism failures are rare, the likelihood of experiencing this problem is very low.
  • 조치
    The manufacturer, McKeeson Medical Imaging, will provide a software update to resolve this issue. Until the issue is resolved end users are advised to ensure that all expected images are present in a study prior to completing the Technologist workflow. Thia action has been closed-out on 28/01/2016

Device

Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 1...
  • 모델명 / 제조번호(시리얼번호)
    Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)ARTG Number: 158895
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd