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 Accuray 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 015 10 18 000
  • Date de mise en oeuvre de l'événement
    2018-10-07
  • Pays de l'événement
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
  • 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
    Accuray incorporated (accuray) has been informed of two issues related to components of the robot contained within the cyberknife® m6™ system. the issues involve the wrist assembly which is the final linkage between the robot arm and the linear accelerator. one issue relates to the fastening process for the wrist assembly which may not have been implemented properly for specific units. the second involves incorrect material being used in a small number of wrist castings. these issues may lead to premature wrist failure, resulting in a linear accelerator fall.

Device

  • Modèle / numéro de série
    Only Accuray CyberKnife M6 Systems may potentially be affected by these issues.
  • Description du dispositif
    Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • Représentant du fabricant
    Gulf Medical Co.
  • Source
    SFDA