Events

Rappel de Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032

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-01528-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-23
  • 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-2016-RN-01528-1
  • 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
    A complaint was received by philips indicating that the non-gated bolus tracking clinical scan failed to initialise with the system displaying the error message:“a problem has occurred; please retry. if the problem persists contact service.” this resulted in the study being cancelled with a loss of bolus. if this were to re-occur, it may necessitate a rescan.
  • Action
    Philips Healthcare will be installing a software update to correct the issue. A Philips Field Service Engineer will contact affected customers to schedule the software update installation at their site. In the interim, customers are advised that when failure occurs the users may : 1. Continue initiating the diagnostic scan manually. 2. Repeat the bolus tracker scan Customers are also advised to use one of the workaround options provided in the customer letter to prevent the failure of non-gated Bolus Tracking clinical scans with dose modulation.

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.X...
  • Modèle / numéro de série
    Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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