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 012 05 11 000
  • Date de mise en oeuvre de l'événement
    2011-05-03
  • 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=374
  • 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
    Ge healthcare has become aware that in the event of a significant power surge, such as one that might be caused by a lightning strike or a utility equipment failure; there is a possibility that the fuse in the mru (magnet rundown unit) circuit could be affected. this situation could indirectly lead to a potential hazard if an emergency magnet quench is required.

Device

Magnetic Resonance Systems
  • Modèle / numéro de série
    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx. Signa HDxt, Signa HFO, GE 1.5T Signa HDe, GE 1.5T Signa HDsv, Signa Excite 1.5T & 3T All MRU units (5196918) shipped to the field between October/01/2009 – December/10/2010 will be included in the fix.
  • Description du dispositif
    The involved systems are whole body magnetic resonance scanners designed to support high resolution and high signal-to-noise ratio images in short exam times. They are indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare