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 Terumo Cardiovascular 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 147 10 18 000
  • Date de mise en oeuvre de l'événement
    2018-10-30
  • 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=13402
  • 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
    This purpose of this medical device correction is to provide users with a revised version of the virtuosaph plus endoscopic vessel harvesting system (vsp550ex) instructions for use (ifu). the vsp550ex ifu contains a list of generators that terumo cardiovascular systems (cvs) has deemed compatible with the vsp550ex device. in response to recent reports received by terumo cvs, it has been determined that the valleylab ft10 energy platform is not compatible with the virtuosaph plus evh system. therefore, the valleylab ft10 has been removed from the list of compatible generators within the vsp550ex ifu.

Device

VirtuoSaph Plus Endoscopic Vessel Harvesting SystemVirtuoSaph Plus Endoscopic Vessel Harvesting S...
  • Modèle / numéro de série
    Catalog Number: VSP550EX Lot Numbers: 81K
  • Description du dispositif
    Electrosurgical, cutting & coagulation & accessories
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Représentant du fabricant
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA