Events

Rappel de Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)

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-2013-RN-00588-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-12
  • 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-2013-RN-00588-1
  • 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 received reports of occurrences where the monitor ceiling suspension (mcs) system fell to its lowest position due to an assembly error of the mcs actuator. in one occasion it collided with the table top.
  • Action
    Philips Healthcare is issuing work around instructions as a temporary measure. The affected MCS actuators will be replaced as a permenant fix.

Device

Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoro...
  • Modèle / numéro de série
    Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)Product codes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025Applies to:Actuator Short Assy: 989600-184-665Actuator Long Assy: 989600-184-654ARTG number: 98560, 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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