Events

Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014 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-00871-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00871-1
  • 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 because studies that have qc, pde or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. use of this product may result in demographic changes to studies not being passed downstream to other pacs servers whether in-house or used for tele-radiology transfers.Not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis as the physician may not receive the required study. there have been no reports of injuries as a result of this issue.
  • 조치
    Emergo is advising users to use DICOM transfers rather than telmed transfers to receiving sites. If there is a valid failure, retrieve the study from archive and resend. It is recommended that logs are reviewed to ensure that all studies have been sent to receiving physicians. Emergo will be implementing a software correction as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture ar...
  • 모델명 / 제조번호(시리얼번호)
    Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia