Events

Rappel de MobileDiagnost wDR 2, all software versions affected (diagnostic 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-2016-RN-00595-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-05-06
  • 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-00595-1
  • 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
    During recent evaluations of the philips mobilediagnost wdr 2, philips has identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions. 1. the system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “normal”), even though the patient type “newborn” was selected and is displayed in the generator control area of the eleva user interface.2. under certain conditions, the detector might not be ready for examination. released x-ray might lead to an image with artefacts and a retake is required. while the attachment process is running, the detector might be too short in front of the ir (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.
  • Action
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)
  • Modèle / numéro de série
    MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)All systems affectedARTG Number: 187112
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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