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 model numbers 2236709, 2353620, 2223039-2 and 2270677-2

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-00181-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-27
  • 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-00181-1
  • 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
    There is a potential for the locking nut to loosen out of the video monitor suspension yoke. this will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut.
  • Action
    A GE representative will contact the affected customers as soon as possible to arrange to check the potentially affected systems and implement permanent corrective actions to mitigate the potential for the failure mode occurring. Meanwhile, GE is asking customers to contact their local GE Healthcare Service Representative immediately if they observe any inappropriate performance or excessive movement of the monitor suspension yoke.

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 model numbers 2236709, 2353620, 2223039-2 and 2270677-2 ARTG number: 93871
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd