Events

Rappel de Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)

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-00927-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-01
  • 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-00927-1
  • 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 issue with the shortened battery life. shortened battery life can lead to a loss of power to devices plugged into the shuttle. power loss during transport most reasonably expected to occur from this battery issue may lead to a minor delay in the transport time.
  • Action
    GE Healthcare is providing work around instructions for users to follow as an interim measure. GE Healthcare is providing a software update as a permanent fix. This action has been closed-out on 20/06/2016.

Device

Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)
  • Modèle / numéro de série
    Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)Giraffe Shuttles with serial number MAAU61001 or higher are not affected by this issue.All shuttles shipped prior to 1 July 2015ARTG Number: 172411
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd