Events

INTELEPACS Versions 4.5.1 to 4.12.1(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-2016-RN-00346-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00346-1
  • 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
    Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred.The user may not be aware that images might be missing. a misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets.
  • 조치
    In order to correct this problem, Intelerad is: 1- providing concerned clients with a list of affected studies and possibly recover the missing images; 2- deploying a software update that includes both a fix and a mitigation for all clients potentially affected by the problem; and 3- periodically auditing all concerned client systems to find and report to the concerned client any new occurrences of this problem until the software update is in place. This action has been closed-out on 27/01/2017.

Device

INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system)
  • 모델명 / 제조번호(시리얼번호)
    INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system) Affected software identifier contains an “R” but with a number below the following:PACS-4-5-1-R77PACS-4-6-1-R85PACS-4-8-1-R46PACS-4-10-1-R36PACS-4-11-1-R28PACS-4-12-1-R4ARTG Number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia