Events

Rappel de Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic 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-2012-RN-00890-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-04
  • 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-2012-RN-00890-1
  • 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
    The patient support may move in an unintended manner if the foot switch cover impinges on the foot switch. damage to the foot switch cover can occur when the couch is lowered and the patient support cover presses down on the foot switch cover and bends it. this can lead to the foot switch cover being deformed in a manner that causes the foot switch cover to engage the unload foot switch. this can lead to unintended movement of the patient support, such as intermittent operation of up and down movement or continued movement when the pedal is released.
  • Action
    Philips Healthcare is providing work around instructions and is planning to replace the sheet metal multi function footswitch.

Device

Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (...
  • Modèle / numéro de série
    Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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