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 Varian Medical Systems.

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 146 03 14 000
  • Date de mise en oeuvre de l'événement
    2014-03-31
  • 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=5567
  • 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
    The shaft of the type 01 elbow motor for exact arms used in the on-board imager® [obi] device have failed due to belt over-tensioning. this over tensioning would have taken place during servicing. this failure would allow the exact arm to swing freely with gravity. no injuries have been reported to-date. only type 01 elbow motors are subject to these potential failures, type 02 elbow motors are not affected.

Device

On-Board Imager
  • Modèle / numéro de série
    Type 01 Elbow Motors
  • Description du dispositif
    On-board imaging (OBI) refers to the use of daily x-rays (taken right on the linear accelerator) that help to confirm a match of treatment setup to the planned treatment.
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • Société-mère du fabricant (2017)
    Varian Medical Systems, Inc
  • Représentant du fabricant
    Varian Medical Systems, Riyadh, (01) 2772126
  • Source
    SFDA