Events

Rappel de Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy and Precision 500D, ADVANTX and Innova 2000 Systems(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-2016-RN-01602-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-09
  • 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-2016-RN-01602-1
  • 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 have been reported incidents of a distar crt monitor that has fallen off the monitor suspension related to product ageing. a fall of a crt monitor could result in a serious injury to a patient or operator. crt monitors, crt monitor feet, and crt suspensions systems have exceeded their nominal life and are obsolete.
  • Action
    GE Healthcare will correct all affected products. A GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, customers are advised of the following: - The CRT monitor & suspension should be inspected & used with caution. Make sure the monitors are secured properly to the tray before each use. Immediately stop using the system in case of any looseness of the monitor noticed contact your GE service representative. - Monitor should not be positioned directly above the patient. - Position the monitor by grasping the handle at the side or front of the tray & gently move to position as recommended in the User Manual 45-296411. - Before service / preventative maintenance of the monitor is attempted on a GE system by non-GE service personnel, GE strongly recommends that they obtain an updated copy of the service and preventive maintenance procedures from a GE Healthcare representative or download from the GE On-Line Documentation website.

Device

Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy and Precision 500D, ADVANTX and ...
  • Modèle / numéro de série
    Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy and Precision 500D, ADVANTX and Innova 2000 Systems(Diagnostic fluoroscopic x-ray systems)ARTG Number: 93871
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd