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 Leica Microsystems 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 097 08 18 000
  • Date de mise en oeuvre de l'événement
    2018-08-29
  • 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=13095
  • 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
    Leica microsystems received five customer complaints stating that users inadvertently tipped over their leica m525 f20 microscope system. in four cases it was confirmed, that the issue occurred when users handled the microscope while the swing arm was in fully extended position (see figure 3 in the attached fsn). in all cases the leica m525 f20 did not cause or contribute to serious injury. the five complaints occurred in five different countries over a timeframe between the years 2010 and 2017. the leica m525 f20 was introduced in the year 2009 with more than 1000 instruments distributed globally up to date.

Device

Leica M525 F20
  • Modèle / numéro de série
    All Leica M525 F20 Microscope Systems
  • Description du dispositif
    Microscopes, Light, Operating
  • Manufacturer
    Leica Microsystems Inc.

Manufacturer

Leica Microsystems Inc.
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Représentant du fabricant
    Al-Faisaliah Medical System
  • Source
    SFDA