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 210 08 15 000
  • Date de mise en oeuvre de l'événement
    2015-08-30
  • 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=8162
  • 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
    Incorrect treatment delivery using third party fixed wedges. when fixed wedges are defined in source file maintenance, the user defines a maximum field size allowed for each wedge. this maximum field size is being ignored by the software when both fixed wedges and mlcs are present in a beam. the result is incorrect calculation and delivery of dose outside the physical extent of the wedge. the dose distribution calculated by xio will not match the dose delivered to the patient in regions beyond the physical dimension of the wedge. varian and siemens linacs will prevent delivery. elekta linacs with motorized wedges will prevent delivery. elekta linacs with third party fixed wedges will not prevent delivery.

Device

XiO Radiation Treatment Planning Systems
  • Modèle / numéro de série
    Sites affected will be those: 1. Running XiO Release 4.51 and higher, and 2. Using Elekta linacs, and 3. Using third party fixed wedges in combination with MLCs
  • Description du dispositif
    Radiation Treatment Planning System
  • 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