Events

Rappel de SIGNA Pioneer MRI System

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-00242-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-03
  • 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-00242-1
  • 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
    There is a potential safety issue with a missing ferrous warning label on the signa pioneer table control box (tcb).Ferrous material in the tcb could cause unexpected attraction to the mr system’s high-strength magnetic field during servicing activities. this could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the tcb from the magnetic field. there have been no events reported as a result of this issue. clinical scanning of patients is not affected by this safety notification.
  • Action
    GE Healthcare will correct all affected products at no cost to the affected customers by applying the ferrous warning label to the TCB. These labels are expected to be available and installed by June 2016. A GE Healthcare representative will contact the affected customers to arrange for the correction.

Device

SIGNA Pioneer MRI System

Manufacturer

GE Healthcare Australia Pty Ltd