Events

IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00223-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00223-1
  • 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
    When loading a study to an analysis application while using url pacs integration configuration, after another study was opened by a review application, the analysis monitor is updated with the study of the current patient but the review monitor continues to display the study from the previous patient.
  • 조치
    Philips Healthcare will be installing a software update to address the above identified issue. As a temporary mitigation, the clinicians have been advised that when reviewing two disparate image datasets, not to only be focused on the actual image content but also to be alerted to the patient’s study name and/or ID prior to interpretation.

Device

IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers...
  • 모델명 / 제조번호(시리얼번호)
    IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration ARTG Number: 188684
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA