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 Philips 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 145 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=5566
  • 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 footboard of patient support for stitching can be fixed in upper position. when the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. if it falls down, it may hurt the operator's or patient's foot (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the board up). following factors are needed that the situation occurs: -hook not correctly adjusted -operator does not recognize that the hook does not click into place -patient support is moved (wheeled around) -hook does not hold -foot in “hazard area”.

Device

DigitalDiagnost X-ray System.
  • Modèle / numéro de série
    All Patient support for stitching are affected
  • Description du dispositif
    X-ray System.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA