Events

Rappel de Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity Flex

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-00031-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-14
  • 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-00031-1
  • 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
    A potential problem with the vertical motor / brake assembly on a manufacturing lot of the patient support / couch was discovered, which may result in uncommanded vertical patient support / couch motion.
  • Action
    End users are advised that when preparing and operating the device end users are advised to take extra caution while the patient is near the patient support. If any un-commanded motion is experienced end users are requested to discontinue use of the device and to contact their local service provider. A Philips Field Service Engineer will service your system to resolve the issue. This action has been closed-out on 15/07/2016.

Device

Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 ...
  • Modèle / numéro de série
    Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity FlexARTG number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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