Events

Rappel de Discovery IGS 730

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-2018-RN-00332-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-13
  • 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-2018-RN-00332-1
  • 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 become aware of a potential loss of imaging mode during an interventional procedure using the discovery igs 730. the discovery igs and innova igs systems may experience x-ray abort errors during a real-time interventional procedure. this issue could potentially happen before or during fluoroscopic use and could result in the loss of imaging capability.To date, there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising that they will be in contact with affected users to arrange installation of the correction.

Device

Discovery IGS 730
  • Modèle / numéro de série
    Discovery IGS 730 ARTG Number: 93871(GE MEDICAL SYSTEMS, AUSTRALIA LTD X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd