Events

Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communications system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-00862-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00862-1
  • 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
    This recall has been initiated due to an issue in which the patient name in the halo title bar may not update to match the name on displayed images due to the java running out of memory. this may result in a mismatch of the displayed patient name on the halo title bar and the displayed images. this may result in a delay in diagnosis or treatment or patient misdiagnosis. there have been no reports of injuries as a result of this issue.
  • 조치
    A released software fix available for this issue. A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. In the interim, Emergo is advising users to ensure the correct patient name is displayed in the Halo title bar. This action has been closed-out on 22/02/2017.

Device

Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communication...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia