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 Barco.

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 144 03 16 000
  • Event Initiated Date
    2016-03-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9068
  • 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
    Robustness issue with the filtering characteristics of an electrolytic capacitor on the invertor board, which might cause inability to drive the monitor's back light. if the monitor fails, the image could turn black and there is no more visual representation of the patient data on this monitor. nevertheless, the patient monitoring system keeps on working and the audible alarms remain available.

Device

Color Monitor (P19STv)
  • Model / Serial
    Q19CSMD (Product Codes: 9919 329 59031; 9919 329 59032; 9919 329 59033)
  • Product Description
    Monitor
  • Manufacturer
    Barco

Manufacturer

Barco
  • Manufacturer Parent Company (2017)
    Barco Nv
  • Manufacturers representative
    Medical regulations gate
  • Source
    SFDA