Events

Rappel de Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (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-2014-RN-01067-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-07
  • 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-01067-1
  • 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
    The epi2alt feature which is a type-in pulse sequence database (psd) recently introduced in the dv25 software release that was intended to help a different brand users transitioning to ge scanners, contains a software issue in which images may be flipped and annotated incorrectly. this image orientation error will affect all axial, sagittal, and coronal diffusion-weighted echo planar imaging (epi) scans using the ‘epi2alt’ type-in (psd) in conjunction with the ‘focus excitation’ option when the number of excitations (nex) is set to larger than 1. no other psds or imaging options are affected by this issue. no injuries have been reported due to this issue.
  • Action
    GE Healthcare recommends that users discontinue use of the type-in ‘epi2alt’ PSD option. Users may continue to use all diffusion-weighted EPI scans available through the user interface.

Device

Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with t...
  • Modèle / numéro de série
    Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System)ARTG Number: 223115
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd