Events

Rappel de OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017

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-2017-RN-00643-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-19
  • 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-2017-RN-00643-1
  • 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 surgery recently identified that product use labels on certain oec elite systems were missing or applied in the incorrect location on the device. the missing labels have the potential to result in users overlooking safe operating practices and exposing themselves or others to potential hazards that may lead to significant harm. to date, there have been no injuries reported because of this issue.
  • Action
    Users are advised they may continue to use the OEC Elite system and to consult the Operator Manual regarding safe use of the system and precautions to be taken: - before initial use of the device - when transporting or moving the system - when connecting, or disconnecting external equipment/accessories - when locking, and unlocking brakes using the brake handle or pedal - when checking/contacting electrical connectors GE Healthcare will contact users to arrange for product correction.

Device

OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017
  • Modèle / numéro de série
    OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017ARTG Number: 132698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd