Events

Rappel de DX-D 600 Digital Radiography System (general purpose x-ray system) Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic SystemsAll serial numbers affected

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-2016-RN-00523-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • 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-00523-1
  • 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
    Agfa has received a report in which the mechanical detent marker on a dx-d 600 became detached. there have been no reports of injuries associated with this issue.
  • Action
    Agfa HealthCare is advising users that if the mechanical detent markers have become loose, to notify Agfa as soon as possible. Agfa will be inspecting all affected units and correcting where required.

Device

DX-D 600 Digital Radiography System (general purpose x-ray system) Products affected: DX-D 600 Di...
  • Modèle / numéro de série
    DX-D 600 Digital Radiography System (general purpose x-ray system)Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic SystemsAll serial numbers affectedARTG Number:173861
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia