Events

Rappel de Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic 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-00462-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-18
  • 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-00462-1
  • 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
    The service procedure describing replacement of a power supply on the rotating side of the gantry specifies the wrong torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could be over-torqued if the component is replaced on your system. in the unlikely event that the bolts fail on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no reports of this issue.
  • Action
    GE has updated the Service Manuals for the affected products to update an incorrect torque value and is advising users to ensure the organisation that services the affected equipment uses the latest version of the Service Manual. The latest version of the Service Manuals can be downloaded from the GE document library. This action has been closed-out on 30/01/2017.

Device

Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diag...
  • Modèle / numéro de série
    Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic systems)CT Scanners:LightSpeed Ultra (8-slice MDAS)LightSpeed Plus (4-slice MDAS)LightSpeed QX/i (4-slice MDAS)LightSpeed 16 (MDAS Only)PET/CT Scanners:Discovery STDiscovery LSARTG Numbers: 96044, 128982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd