Events

Rappel de DX-D 100 Digital Radiography X-Ray SystemAll Units

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AGFA HealthCare Australia.

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-00674-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-25
  • 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-00674-1
  • 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
    When liquid comes in contact with the dx-d 100 touch screen, the device may incorrectly recognise this as user input altering device settings. capacitive touch screens rely on the electrical properties of the human body to enable users to operate the device with very light touches of a finger. however, when liquid comes in contact with the touch screen it may incorrectly recognise this as user input. for example, it could unexpectedly change the exposure settings.
  • Action
    Users are advised that they must ensure their hands are dry before using the touch screen of the DX-D 100 because liquid residue may activate the action buttons on the touch screen. The following advice is provided in the customer letter in addition to referring users to the warning in the user manual:: - Do not operate touch screen monitor with wet hands. - Do not let liquids come in contact with the touch screen while the DXD 100 is powered on. - Always double check your parameter settings prior to exposing the patient.

Device

DX-D 100 Digital Radiography X-Ray SystemAll Units
  • Modèle / numéro de série
    DX-D 100 Digital Radiography X-Ray SystemAll UnitsARTG Number: 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia