Events

Rappel de Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Cardiovascular X-ray imaging systems equipped with Video Monitor Suspension (Fluoroscopic, angiographic 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-2013-RN-00899-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-23
  • 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-00899-1
  • 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 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 system has not been installed per specified installation requirements. the missing screws may increase the risk for fall of the monitor suspension.
  • Action
    GE Healthcare is inspecting all potentially affected systems to verify that the overhead Video Monitor Suspensions are properly installed and will correct all affected systems.

Device

Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Ca...
  • Modèle / numéro de série
    Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Cardiovascular X-ray imaging systems equipped with Video Monitor Suspension (Fluoroscopic, angiographic x-ray system)ARTG Number: 93871
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd