Events

Rappel de Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor

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-00016-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-09
  • 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-00016-1
  • 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 involving the overhead lcd video monitor suspension. there is a potential for the locking nut to loosen out of the lcd video monitor suspension yoke. this will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. to date, no injury has been reported due to this.
  • Action
    GE Healthcare is advising users that if inappropriate performance or excessive movement of the monitor is observed to immediately contact GE Healthcare. GE Healthcare is correcting all affected systems.

Device

Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor
  • Modèle / numéro de série
    Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor Model Number: 2385123-2 LCD Video Monitor Serial Number: 00000001386MC2ARTG Number: 99423
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd