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 Medical Systems..

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 033 01 11 000
  • Date de mise en oeuvre de l'événement
    2011-01-17
  • 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=5&rid=48
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    1. when using the center on cursor feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr will move to a position where the 3d cursor is centered on the screen. 2. when using the isocenter move mode feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr is correctly recalculated and shown. 3. when the image series is changed (on the top left corner of a drr view) while using drr blending, the captured drr is not recalculated or cancelled. 4. when using the blended drr function the visualization of the captured drr may change without the visualization parameters (mixing and depth control) being updated on-screen after choosing a drr preset for the active drr. 5. when a new beam is created after using drr blending on a previous beam, switching back to the previous beam may cause annotations for blending, mixing and depth control to not be shown.

Device

Advantage Sim MD.
  • Modèle / numéro de série
    Software version: 5.x, 6.x, 7.x
  • Description du dispositif
    Software for X-ray system, used for radiotherapy.
  • Manufacturer
    GE Medical Systems.

Manufacturer

GE Medical Systems.
  • Société-mère du fabricant (2017)
    General Electric Company
  • Représentant du fabricant
    GE Healthcare., Riyadh, (01) 4600530
  • Source
    SFDA