Events

Rappel de GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455)

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-2015-RN-00699-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • 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-2015-RN-00699-1
  • 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 the service procedure used to replace a power supply on the rotating side of the gantry specified the incorrect torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could have been over-torqued when the component was replaced on your system. plastic deformation of the bolts from over-torqueing could worsen over time and eventually fail. however, all 3 bolts holding the power supply would have to fail for the part to fall. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no incidents or injuries reported as a result of this procedure error.
  • Action
    GE Healthcare will correct all affected products at no cost to users. This action has been closed-out on 15/08/2016.

Device

GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Powe...
  • Modèle / numéro de série
    GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455) Affected Product: The following CT Scanners, manufactured from 2003 – 2006:· LightSpeed Ultra (8-slice MDAS)· LightSpeed Plus (4-slice MDAS)· LightSpeed QX/i (4-slice MDAS)· LightSpeed 16 (MDAS Only)The following PET CT Scanners, manufactured from 2003 – 2005:· Discovery ST· Discovery LS ARTG Numbers: 96044 and 156649
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd