Events

Rappel de GE Signa Magnetic Resonance Imaging System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Medical Systems LLC.

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
    14656
  • Date de mise en oeuvre de l'événement
    2013-05-16
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    For clariview and screen save from gvtk (gems visualization 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. in all cases, patient identifying annotation remains correct.
  • Action
    Software to be upgraded

Device

GE Signa Magnetic Resonance Imaging System
  • Modèle / numéro de série
    Model: Models: 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, Affected: PACS systems manufactured by Intelerad (IntelePACS 4-3-1-P350 and InteleBrowser -4-3-1-P350)
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC