Events

Rappel de Proteus XR/a X-ray 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-2014-RN-01300-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-12
  • 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-01300-1
  • 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
    It was reported that both the steel cables in a proteus system wall stand failed and the bucky cabinet (68kg) fell to the floor. the unit was not in use, no patient or operator injury was reported. the proteus wall stand assembly associated with this event was identified as model 600-0301. the steel cable used with this wall stand is 603-3220. an investigation concluded that the root cause was fatigue of the braided rope.
  • Action
    1. GE Healthcare will correct all affected systems by replacing the steel cables at no cost. A GE Healthcare service representative will contact customers to arrange for this correction. 2. To prevent occurrence of these issues in the future, the Service Procedures including the service interval for periodic cable maintenance and replacement is also being updated. The updated Service Procedure (2273022-100 Rev 31) will be available by 15th Jan 2015 at a website link that is to be provided in the Customer Letter. This ation has been closed-out on 11/08/2016.

Device

Proteus XR/a X-ray Imaging Systems

Manufacturer

GE Healthcare Australia Pty Ltd