Events

Rappel de MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer MRI systems running application software version DV25.1

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-01213-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-19
  • 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-01213-1
  • 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 with the magic imaging application. images may exhibit novel artefacts on magic t2 flair synthetic reconstructions that may be difficult to recognise without access to conventional t2 flair weighted images. this issue has the potential to lead to misinterpretation of the magic images when making medical diagnosis or treatment decisions. with magic acquisition all contrasts are acquired simultaneously, therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artefacts. there have been no injuries reported as a result of this issue.
  • Action
    GE will be correcting all affected products and providing MAGiC operator documentation Release Notes. In the interim, GE is advising users that they may continue to use MAGiC with the following precautions: Exercise caution when reviewing CSF spaces, its adjacent tissues and the posterior fossa, particularly for cases involving subtle pathology. If in doubt, it is advisable to acquire a conventional 2D or 3D T2 FLAIR series or a MAGIC series in a different orientation for cross-sequence comparison. It is always recommended to pay close attention to patient stabilisation during scanning. Attention should be given to prior cases as they may be affected by this safety issue. For historical data inquiries, contact GE service for assistance in identifying any affected images. This action has been closed out on 15 June 2017.

Device

MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer MRI systems running application sof...
  • Modèle / numéro de série
    MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer MRI systems running application software version DV25.1 ARTG Number: 252692
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd