Events

GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture archiving and communication system, PACS) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-2013-RN-01077-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01077-1
  • 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
    The gsi viewer application running on aw/volume share or on the aw server when making a batch and rotating the batch group clockwise 180 degrees (inferior to superior) will display images in the superior orientation. the orientation annotation on the image is correct. the concern is that the patient right/left representation is from the superior view, which could result in a misreading of the image and misdiagnosis.
  • 조치
    GE Healthcare is advising users that the orientation annotation is correct on the image, and to always correlate any information in any 3D reconstruction with the original data. GE Healthcare advises that a software correction will be installed on all affected systems by March 2014.

Device

GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture arc...
  • 모델명 / 제조번호(시리얼번호)
    GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture archiving and communication system, PACS)ARTG Number: 161257
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd