Events

Rappel de Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxx

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-2015-RN-00068-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-28
  • 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-2015-RN-00068-1
  • 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 identified a software defect that may result in the scanner updating the planned scan length to be longer than the user intended. this may happen if:1. the exam is planned with low pitch and rotation time values, for example, 0.3 pitch and 0.27 rotation time, and2. the plan scan length is increased or lengthened on the surview/scout, and3. the system displays a pop-up message that the current pitch, rotation time, and planned scan length are incompatible and suggests a new pitch and rotation time. 4. if the user accepts the suggested pitch and rotation time changes, the system adjusts the plan to the maximum allowed scan length, which will plan the study beyond the original intended length.
  • Action
    Philips is providing instruction to assist identify if a system is affected and advising end users to ensure that the scan length is verified prior to initiating the scan. A Philips Field Service Engineer will contact affected customers to arrange for the software to be updated. This action has been closed-out on 19/07/2016.

Device

Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2...
  • Modèle / numéro de série
    Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxxARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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