Events

Rappel de IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2(Processes clinical images from different imaging modalities i.e., CT, NM, MR and enables advanced visualisation)

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-00977-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-11
  • 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-00977-1
  • 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
    The following issues could lead to misdiagnosis which may result in patient mistreatment:1. when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed may be different from the ef originally displayed when the bookmark was first created. 2. when processing using autoquant, emory cardiac toolbox, corridor4dm, or neuroq nm clinical applications, the patient study presented to the reviewing physician may be for a different patient than the one selected from the patient directory. 3. while using the nm viewer application, an arrow annotation added to a display moves away from its original position if the viewer is maximised or if the image is zoomed in or out. 4. while displaying pet images within ct viewer, the suv results displayed are different from the one specified in system preferences. this issue affects the ct viewer and multi-modality tumour tracking applications.
  • Action
    Philips Healthcare is providing users with temporary workarounds in the customer letter for the identified problems. The issues have been corrected in software versions 5.0.2.3 and 6.0.2.3. Philips Service Engineer will contact the customers for implementation of the software update on the affected systems. This action has been closed-out on 9/08/2016.

Device

IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2(Processes clinica...
  • Modèle / numéro de série
    IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2(Processes clinical images from different imaging modalities i.e., CT, NM, MR and enables advanced visualisation)Models:IntelliSpace Portal DX/HX/EX IntelliSpace Portal IXIntelliSpace Portal LX SPECTARTG Number: 188684
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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