Events

Rappel de Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5

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-2016-RN-00680-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-26
  • 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-2016-RN-00680-1
  • 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
    Philips healthcare became aware of certain issues with the affected products through testing & customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels;- missing image annotations in cct- halo artefacts- incorrect z annotation on plan box for coronal/sagittal surviews- post injection delay between timed scans may be inaccurate- unintended change of acquisition timing on scan ruler- bolus tracker does not trigger as expected- cardiac step & shoot stops after arrhythmia detected- tracker scan halted with fdom- error when auto roi placement outside patient anatomy- no "go" when hr outside acceptable range- unplanned results during multi-phase pulmo series, may cause a system crash- dynamic myocardial perfusion acquisition halted after 1st shot- double clicking ecg phase bar crashes exam application- incorrect phase tolerance for cardiac s&s; &- ring artefacts on high resolution images, idose4 & imr.
  • Action
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5

Manufacturer

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