Events

Rappel de 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance 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-2013-RN-00454-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-16
  • 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-2013-RN-00454-1
  • 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
    For clariview and screen save from gems visualisation toolkit viewer, the mr product can generate image headers with non-unique series identifiers, which when exported to some pacs systems, results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. patient identifying annotation remains correct. note that related issues have only been seen on pacs systems manufactured by intelerad (intelepacs 4-3-1-p350 and intelebrowser -4-3-1-p350) at this time.
  • Action
    GE Healthcare is providing temporary work around instructions and implementing a software update to correct the issue.

Device

1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems)
  • Modèle / numéro de série
    1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems)ARTG Number: 108415
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd