Events

Rappel de Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)

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-00417-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-07
  • 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-00417-1
  • 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
    An issue has been found with the ingenuity core128 system with software version 3.5.5. if additional acquisitions/scans are requested prior to completion of the current reconstructions, not all planned images from the current reconstruction are displayed to the user. users may not be aware the information is not lost, as the raw data can be reconstructed off-line displaying all requested reconstructions. if a rescan is required, there is potential for unnecessary radiation.
  • Action
    Philips is requesting customers to verify that all planned image reconstructions are completed and to perform off-line reconstructions, if expected images are missing. Philips will be installing a software update to correct the issue. This action has been closed-out on 01/02/2016.

Device

Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray s...
  • Modèle / numéro de série
    Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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