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 085 04 12 000
  • Date de mise en oeuvre de l'événement
    2012-04-24
  • 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=1716
  • 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
    It is possible that the backup diaphragms drive mechanism can become loose after many years in clinical operation. this can cause a backlash between the positioning mechanism and the diaphragm. this backlash can be seen by the usual x-ray and field calibration checks when the field is moved from a small to a large field size. if there is a problem it will be that the backup diaphragm is not in the correct position behind the mlc leaf tips. if you do not do the recommended planned maintenance program, screws can become lost from the positioning mechanism. if you find one or more screws, do not use the machine for clinical operation, and find the cause.

Device

Radiology, X-ray, MLCi and MLCi2 radiation heads
  • Modèle / numéro de série
    All MLCi and MLCi2 radiation heads.
  • Description du dispositif
    Radiology, X-ray
  • 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