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 Elekta Inc.

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 013 10 12 000
  • Date de mise en oeuvre de l'événement
    2012-10-08
  • 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=2458
  • 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
    A patient was mistreated after a user made and saved an inadvertent change to the definition of a treatment field in mosaiq. the field edit delta display feature is designed to minimize the risk of applying inadvertent changes to the treatment field definition form. it lists and/or highlights the changes to the treatment field definition form since the last approval or delivery of the associated treatment field. the field edit delta display feature was introduced in mosaiq version 2.00n2 as a configurable risk mitigation (i.E. shipped enabled, but users with appropriate permissions could disable it). the mistreatment occurred at a site that had disabled the feature. after the mistreatment, a risk re-assessment was completed. it was concluded that the risk outweighed any benefit of allowing users to disable the feature. the feature was made non-configurable (i.E. users cannot disable it) in mosaiq version 2.41.01e5.

Device

Radiotherapy software, MOSAIQ
  • Modèle / numéro de série
    Reference: CAR0271
  • Description du dispositif
    Radiotherapy software
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Société-mère du fabricant (2017)
    Elekta AB
  • Représentant du fabricant
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA