Events

Rappel de Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT 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-2012-RN-01187-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-23
  • 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-2012-RN-01187-1
  • 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. during an interventional procedure with an interventional exam card reconstruction increment set to a negative value, one exposure of cct was not reconstructed – there was radiation but images were not updated on the screen. 2. when moving the couch using the gantry buttons during an interventional procedure & the user chooses an interventional exam card with the reconstruction increment set to a negative value, the user has to wait a few seconds for the new position to update. there is an image update delay at about 5 second intervals. 3. when reconstructing images with o-mar the system may fail to provide a non-omar set of images as required. the non-omar images must be manually reconstructed. 4. the rotor begins to spin without waiting for service personnel to request the go command. 5. incorrect cbv values in the brain perfusion application may occur if the user takes brain perfusion images from a ge scanner into a specific application installed on a philips scanner.
  • Action
    Philips is provided work around instructions for the issue and will be implementing a software update to correct the problem.

Device

Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software ver...
  • Modèle / numéro de série
    Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT systems)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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