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 Visionsense Ltd.

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 060 06 11 000
  • Date de mise en oeuvre de l'événement
    2011-06-18
  • 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=5&rid=535
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    May have an improperly sealed metal and glass window in the tip of the scope and possibly a mis-assembled camera head positioned behind the window. this combination of factors may lead to the metal and glass window becoming dislodged from the scope tip during cleaning and render the unit inoperable. the metal and glass window may also become dislodged during use therefore may represent a potential health hazard.

Device

Laparoscope Integrated Camera, VS II
  • Modèle / numéro de série
    VSII Laparoscope Integrated 0 Deg Camera. 30 Degree cameras are fit for use and are not affected by this recall.
  • Description du dispositif
    Cameras, Video, Endoscopic
  • Manufacturer
    Visionsense Ltd

Manufacturer

Visionsense Ltd