Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 057 04 12 000
  • Date de mise en oeuvre de l'événement
    2012-04-17
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1688
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    When using the fmri protocol in ready view, the ready view application may incorrectly sort the phases of the fmri native data set. this happens when the fmri data was acquired using the brainwave rt acquisition scheme on the mr console. no adverse event has been reported related to this issue. this affects the analysis of the image set made by the correlation algorithm used in the fmri protocol. as a result, activated pixels identified as having a high correlation with a reference pattern may not be correctly identified.

Device

Workstation software, READY View
  • Modèle / numéro de série
    READY View version 10.3.67 is affected; PR# 7130256 to AFSSAPS (reference 201205472)
  • Description du dispositif
    Workstation software, analyzing fMRI images
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare