Events

Rappel de Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)

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-2013-RN-01089-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-23
  • 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-2013-RN-01089-1
  • 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 recently become aware of a potential safety issue related to the manual film composer feature on some ct products. while following a specific workflow, there is potential to create a film image with one patient's images and another patient’s name in the footer. there is also another issue when within manual film composer, if a colour image is selected for printing, another patient’s black and white image appears in the preview screen and the colour image cannot be printed.
  • Action
    As a temporary work around, GE is asking customers to always review the patient images and patient name on footer in the Manual Film Composer feature to ensure that they match . GE is providing temporary work around instructions on how to print the colour image from the Manual Film Composer. GE Healthcare will undertake a software update on each affected system as a permanent solution.

Device

Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)
  • Modèle / numéro de série
    Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)ARTG Number: 93337
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd