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 Natus Medical Inc.

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 018 06 12 000
  • Event Initiated Date
    2012-06-04
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1876
  • 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
    1- small number of instances where the olymoic cool-cap systems control module has experienced a frozen screen during the treatment of infants. 2- small number of instances where the power supply within the cooling module of the olympic cool-cap system has faield.

Device

Olympic Cool-Cap system
  • Model / Serial
    Serial numbers 7048,7258,7265,7267, 7270-7273,7275,7278-7280, 7282-7285,7288,7290-7292,7294
  • Product Classification
    Neurological Devices
  • Product Description
    Cool Cap, Screen
  • Manufacturer
    Natus Medical Inc

Manufacturer

Natus Medical Inc
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Manufacturers representative
    Techno-Orbits Establishment, Riyadh, (01) 2293 142
  • Source
    SFDA