Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Philips Burton.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 016 10 17 000
  • Event Initiated Date
    2017-10-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11588
  • Notes / Alerts
    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.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    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
  • Model / Serial
    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.
  • Product Description
    Adaptive Security Appliance (ASA) 5506 firewall
  • Manufacturer
    Philips Burton

Manufacturer

Philips Burton
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA