Events

Rappel de Allura Xper Systems(Fluoroscopic angiographic digital 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-01104-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-10
  • 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-01104-1
  • 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
    If a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. this might cause an intermittent or continuous inability of making live fluoroscopy images or exposures. in case the fluoroscopy pedal is bent and live fluoroscopy is not available, the exposure pedal of the footswitch or the hand switch may be used to generate a live image in order to finish a procedure, this will lead to a higher dose but it outweighs the potential safety risk.
  • Action
    Philips Healthcare is advising the customers to check the footswitch for bent pedals before the start of a procedure and if bent pedals are found the procedure should not continue and local Service should be contacted. Philips Healthcare is performing the hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoroscopy images or exposures. This action has been closed-out on 11/08/2016.

Device

Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)

Manufacturer

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