Events

Rappel de Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)

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-00197-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-03-04
  • 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-00197-1
  • 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
    1- swirl-like ring artifacts may appear on reconstructed images impairing the diagnostic quality.2- when executing two bolus scans the system may freeze during the second tracker execution, impacting countdown timer displayed to the user which indicates the start of the clinical scan. 3- there are inconsistencies between the gui and the instructions for use (ifu)/technical reference guide (trg): english version 459800340361_a documentation for the (qa) testing4- teflon and other pins hu values are incorrectly documented in the ifu/trg.
  • Action
    Philips is provided information and work around instructions to mitigate some of the issues. A software update and revision of the Instructions for Use (IFU) documentation will be implemented to correct the issue.

Device

Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole ...
  • Modèle / numéro de série
    Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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