Events

Rappel de DX-D 600 X-ray System, Versions below 3.6

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-01247-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-27
  • 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-01247-1
  • 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
    The unit is equipped with safety measures to ensure no movement can occur without user interaction. however, a customer complaint reported that during normal movement’s isolated cases of unintended overhead tube crane acceleration occurred.
  • Action
    Users are advised that in the case of an accelerated movement, release the button/pedal immediately to stop the unit and notify their Agfa HealthCare service contact at once. Agfa Healthcare will be upgrading all full automatic and semi-automatic DX-D 600 devices to Version 3.6 to eliminate this issue. This action has been closed-out on 12/08/2016.

Device

DX-D 600 X-ray System, Versions below 3.6
  • Modèle / numéro de série
    DX-D 600 X-ray System, Versions below 3.6All full automatic & semi-automatic devices below version 3.6ARTG Number: 173861
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia