Events

Rappel de Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems

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-2016-RN-00001-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-04
  • 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-00001-2
  • 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 become aware of a potential safety issue related to the operation of the safety latch holding mechanism for the horizontal arm of the x-ray system. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. in order to encounter the hazardous situation where the x-ray tube horizontal arm falls, it would require the following condition to occur simultaneously which is highly unlikely:1) the counter weight cable system (steel cable or pulley/idler) breaks.2) the safety mechanism does not engage and hold the tube–arm there have been no incidents or injuries reported as a result of this internally found issue.
  • Action
    GE Healthcare will correct all affected products. In the interim, users are advised to continue to use the system with caution. This action has been closed-out on 27/01/2017.

Device

Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
  • Modèle / numéro de série
    Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systemsAll serial numbersARTG Number: 201698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd