Events

Rappel de Discovery XR656 Wall Stand System (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 GE Healthcare Australia Pty 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-2014-RN-00834-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-25
  • 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-00834-1
  • 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
    Ge healthcare has recently become aware of two flashpad detector falls due to a broken nylon support hook. a detector fall could result in an injury to a patient or operator. there have been reported incidents of detector falls, but no injuries have been reported.
  • Action
    Users are advised that if they observe either one of the nylon support hooks as broken or loose on the Discovery XR656 wall stand system, immediately stop use and contact their local GE Healthcare Service Representative. If the hooks are not broken, users may continue to use the wall stand system. GE Healthcare is correcting all affected systems by replacing the nylon hooks. This action has been closed-out on 03/06/2016. This action has been closed-out on 03/06/2016.

Device

Discovery XR656 Wall Stand System (X-ray system)
  • Modèle / numéro de série
    Discovery XR656 Wall Stand System (X-ray system)Part Numbers: 5374989 and 5397837Serial numbers: 00000100365HL6, 00000099847HL6, 00000109154HL5, 00000108716HL2, 00000109561HL1, 00000109564HL5ARTG Number: 167617
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd