Events

Rappel de Brilliance iCT with Software Version 4.1.0.19260

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-01333-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-18
  • 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-01333-1
  • 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 has detected a situation where ring artifacts may occur. the conditions that may create these specific ring artifacts occur when a user:1. selects a non-gated helical scan with automatic scan time on 2. they edit the preview images using ‘edit before final recon’ (reconstruction); and,3. the automatic scan time algorithm is executed after the scan has been acquired.Presence of ring artifacts affecting diagnostic quality of images may result in a rescan.
  • Action
    To avoid the occurrence of these specific ring artifacts users can implement the following work around: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking 'Go' to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Reconstruction for all Exam Cards. If ring artifact is present clinical judgement should be used to determine if rescan is required. A software update will be implemented to correct the problem.

Device

Brilliance iCT with Software Version 4.1.0.19260

Manufacturer

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