Events

Rappel de Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

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-2015-RN-00116-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-11
  • 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-2015-RN-00116-1
  • 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 breakage of the steel cable which support the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator. there were no injuries reported as a result of this issue.
  • Action
    GE Healthcare will inspect, and repair as necessary, all affected systems. A GE Healthcare service representative will contact customers to arrange for this correction. Additionally, the Service Procedure which defines the service interval for periodic cable maintenance and replacement is being updated to require a cable replacement every 15 years, and specify annual inspections of the counterweight guide rail bolt paint marking to confirm tightness of the bolt. This is to ensure the ongoing safe operation of this device. This action has been closed-out on 16/02/2016.

Device

Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

Manufacturer

GE Healthcare Australia Pty Ltd