Events

Rappel de IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)

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-2014-RN-00952-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-02
  • 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-2014-RN-00952-1
  • 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
    In philips intellispace pacs 4.4, there is feature which allows the optional configuration of auto export of resolved study exception immediately after resolution. when this configuration is used, it is possible for a system timing issue to occur when exporting data to 3rd party devices. if this system timing issue occurs when demographics are updated, such as during exception resolution and the study is immediately exported, the patient demographic information can be incorrect in the exported data. although the data is correct in intellispace pacs if diagnosis is performed on this exported data using a 3rd party device the user may not be aware of unchanged patient data is being utilised. if this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient. the hazard involved is that diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient.
  • Action
    Each site will be contacted by Philip’s Technical Account Manager and notified if Auto Export is configured at the site and to schedule either the disabling or the correction of the Auto Export Feature. Determined by site utilization of the feature, Philips will schedule and deploy software correction or will disable the Auto Export Feature for all IntelliSpace 4.4 installations impacted by this issue. This action has been closed-out on 17/08/2016.

Device

IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)
  • Modèle / numéro de série
    IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)All versions of IntelliSpace PACS 4.4 with Auto Export Feature Enabled are affectedARTG Number: 178437
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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