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 Radiometer Medical.

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 035 12 12 000
  • Event Initiated Date
    2012-12-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2698
  • 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
    Radiometer have recently become aware that there is a potential risk of electrical shock for the operator. the electrical shock may appear under the following conditions: • the monitor is connected to the mains outlet and the mains switch is on • the battery is fully charged (or no battery is present) • the operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor off • the operator touches the two metal pins on the mains plug or on the monitor’s line cord receptacle after disconnecting the line cord.

Device

Monitors, Bedside, Blood Gas, TCM4 series Base Unit
  • Model / Serial
    • All TCM4 series Base Units with serial numbers starting with: 000-154, 391-876, 391-878. • TCM4 series Base Unit with serial numbers of 391-880 below R0175N009. • Spare part Power Supply, 910-246.
  • Product Description
    Monitors, Bedside, Blood Gas
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA