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 Burton.

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 016 10 17 000
  • Date de mise en oeuvre de l'événement
    2017-10-02
  • 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=11588
  • 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 defect involves the clock signal component within the firewall. this component has a high probability of failing in appliances that have been running for greater than 18 months. if the clock signal component were to fail, the firewall will stop functioning, will not boot, and is unable to recover from the component failure. this failure will result in a loss of communication between devices that are separated by the firewall, which may cause the information center to reboot.

Device

Philips Network, Cisco Adaptive Security Appliance (ASA) 5506 firewall
  • Modèle / numéro de série
    Philips Network Firewall 867098 (Cisco ASA 5506 Firewall) used with the Philips IntelliVue Information Center iX or Classic Information Center. Any appliance with a serial number less than JMX2050000 are affected.
  • Description du dispositif
    Adaptive Security Appliance (ASA) 5506 firewall
  • Manufacturer
    Philips Burton

Manufacturer

Philips Burton
  • Société-mère du fabricant (2017)
    Philips
  • Représentant du fabricant
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA