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 CMS Inc Div Elekta AB.

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 070 07 11 000
  • Date de mise en oeuvre de l'événement
    2011-07-18
  • 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=667
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The xio software currently prompts users to enter ct to electron density data for a study set. electron density should be used for photon and electron calculations. proton broad beam and pencil beam calculations should use relative stopping power and proton spot beam calculations should use mass density. no indication is given that electron density data should only be used for photon and electron calculations and that either relative stopping power or mass density should be used for proton calculations (depending on the algorithm). use of electron density instead of mass density could result in errors of up to 5% for dense bone and up to 8% for densities greater than 2 gm/cm3. the problem occurs when defining a ct to ed table in xio and has existed since xio release 2.4.0, however it only affects xio sites with machines capable of creating protons for treatment.

Device

Radiation therapy, Treatment planning system software, application program, XiO
  • Modèle / numéro de série
    XiO versions equal to or greater than 2.4.0 and less than 4.63.0
  • Description du dispositif
    Radiation, Treatment, Planing, Workstation
  • Manufacturer
    CMS Inc Div Elekta AB

Manufacturer

CMS Inc Div Elekta AB
  • Société-mère du fabricant (2017)
    Elekta AB
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh, (01) 2119999
  • Source
    SFDA