Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00223-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-12
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00223-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA