Events

Rappel de Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems) Installed on INNOVA 2100, 3100 fluoroscopic imaging systems.

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-2016-RN-00003-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-04
  • 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-2016-RN-00003-2
  • 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 become aware of a reported incident in which a mavig suspension arm with monitor assembly fell to the floor. the failure of spring arm rotating plate will lead to a sudden fall of the spring arm with monitors of mavig suspension. such a fall could result in bodily harm to a person. there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare will correct all affected products. In the interim, users are advised to avoid placing the monitor over a patient, or user or other auxiliary personnel. If users observe any unusual movement or looseness of the Mavig Monitor suspension, they are advised to contact their GE Healthcare representative and follow the precautions below before continuing to use the monitor(s): 1) Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2) Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. GE Healthcare will send a representative to inspect the system. This action has been closed-out on 04/05/2017.

Device

Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imag...
  • Modèle / numéro de série
    Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems)Installed on INNOVA 2100, 3100 fluoroscopic imaging systems.ARTG Number: 93871
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd