Events

Rappel de Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution

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-01595-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-12
  • 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-01595-1
  • 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
    There is an electrical component called mr-or laser control board in the flextrak or trolley, under the interface adapter. in production, two mr-or laser control boards have been found where the laser control board has been assembled incorrectly, leading to insufficient isolation distance. hence, there is a possibility that a patient or user may be exposed to a very small, level of touch current. in practice, the current is so low that it may not even be noticed.
  • Action
    Philips has revised the design of the control board and is sending out service engineers to install the revised boards.

Device

Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution
  • Modèle / numéro de série
    Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution ARTG Number: 230064
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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