Events

Rappel de Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray 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-2013-RN-01299-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-09
  • 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-2013-RN-01299-1
  • 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
    It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that the systems have not been installed per specified installation requirements. ge healthcare is not aware of any fall of the overhead monitor suspension; however, missing screws may increase the risk for fall of the monitor suspension.
  • Action
    GE Healthcare is inspecting all potentially affected systems to verify the overhead Video Monitor Suspensions are properly installed and will correct all affected systems.

Device

Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Pres...
  • Modèle / numéro de série
    Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray systems)All CRT monitors installed from January 1993ARTG Number: 99423
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd