Events

INTELEVIEWER Versions 3.8.1 P355 and up (radiology picture archiving and communication 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-2014-RN-00292-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00292-1
  • 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
    Intelerad recently discovered a software defect where if you view reports in inteleviewer, you will not see the symbol "<" if it was used in the report. if you view reports in the ris, in intelebrowser, or in inteleconnect, you will see the proper version of the report with the "<" symbol if it was used.
  • 조치
    Emergo Australia will contact their customers to arrange for a software update as soon as the update is complete. End users are advised to view reports in the RIS, in InteleBrowser or in InteleConnect until the software problem is corrected. A customers account manager will be in contact immediately to disable to affected feature.

Device

INTELEVIEWER Versions 3.8.1 P355 and up (radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia