Events

Rappel de Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurations

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-00143-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-10
  • 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-00143-1
  • 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 become aware of a potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. a potential life-threatening hazardous situation may occur if there is unintended radial detector motion leading to a patient contact. this failure mode has been observed on a single system for a whole body scan, in which detector moved to the home position and then slowly started drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry.
  • Action
    GE Healthcare is providing safety instructions to prevent any patient injuries if this failure mode occurs in the field. A GE Healthcare Service representative will perform the required service action (that includes a software update) on each affected system.

Device

Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All conf...

Manufacturer

GE Healthcare Australia Pty Ltd