Events

Rappel de OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected.

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-2014-RN-00389-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-02
  • 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-2014-RN-00389-1
  • 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 screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to fall forward.
  • Action
    A GE HealthCare Field Engineer will replace the screwS to ensure that the system is operating safely and meets all specifications. Until the correction is complete, end users are advise to use caution when positioning or extending the arm. In addition, refrain from positioning staff or patients directly underneath or in front of a work station monitor.

Device

OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9...
  • Modèle / numéro de série
    OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected. ARTG Number: 132698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd