Events

Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a 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-2016-RN-00870-1
  • 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-00870-1
  • 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
    Unviewed images may not display after the last hanging protocol (hp) step when the user preference setting "show unviewed images after the last hanging protocol (mg only)" is selected. this can occur if the last hp step was skipped. this is most commonly encountered if there are additional views created for the study.This may impact diagnosis when images are unavailable for viewing, however there have been no reports of injuries as a result of this issue.
  • 조치
    Emergo is advising users to not have the red-x icon available in the reading physician's toolbars to close the study. This will trigger a warning message that there are unviewed images available. Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 27/02/2017.

Device

Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS vers...
  • 모델명 / 제조번호(시리얼번호)
    Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia