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 Radiometer Medical.

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 092 11 12 000
  • Date de mise en oeuvre de l'événement
    2012-11-21
  • 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=2613
  • 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
    A buffer overflow may occur on the main board during a flush, which takes place when the aqt90 has been idle for more than 6 hours. the overflow could cause the analyzer to enter into an error stage with different error messages and would require a restart of the analyzer to proceed. this stage is known as the “usb software error”. in some situations the analyzer would lose current calibrations requiring a recalibration. this means that the temporary workaround described in the technical bulletin – to restart the analyzer when it has been idle for more than six hours – is no longer necessary.

Device

Blood gas analyzer, AQT90 FLEX
  • Modèle / numéro de série
    AQT90 software version: V8.4.22
  • Description du dispositif
    AQT90 FLEX, analyzer
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Représentant du fabricant
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA