Events

Rappel de DuraDiagnost X-ray systems

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-00925-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-12
  • 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-00925-1
  • 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
    Duradiagnost systems provide an audible exposure termination signal (beep) through the speaker integrated into the monitor. however, buttons or keys on the monitor allow the user to turn the volume setting down to “0”, in which case the beep will not be heard at the conclusion of an exposure. note that the current volume setting is displayed when the buttons or keys are depressed. if the monitor volume is set to “0”, the absence of an audible exposure termination signal may lead the operator to assume that an exposure was not performed correctly and therefore unnecessarily repeat the patient exposure.
  • Action
    Philips is advising users to check the volume of the monitor to ensure it is not set to '0'. Philips will be implementing a software upgrade as a permanent correction.

Device

DuraDiagnost X-ray systems

Manufacturer

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