Events

Rappel de GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016

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-00502-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-27
  • 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-2016-RN-00502-1
  • 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 that an out of tolerance torque tool was used on three joints on your revolution ct system during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artefact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users that the scanner can continue to be used. If the X-ray Tube joint loosens, the system would fail internal checks and cause the previous mentioned hazards of beam tracking errors, potential scan aborts and/or image artefacts, requiring immediate action by service to realign the system. Should this occur, stop using the system and call the service team to bring the system back into proper operational status. GE Healthcare will be correcting all affected products. This action has been closed-out on 27/01/2017.

Device

GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016
  • Modèle / numéro de série
    GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016ARTG Number: 156650
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd