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 Varian Medical Systems.

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 066 08 11 000
  • Event Initiated Date
    2011-08-22
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=775
  • 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 4d integrated treatment console (4ditc) is scheduled for a mandatory upgrade from your current version to 10.2. the reason for the upgrade is to ensure customers have the most current version of 4ditc which contains several improvements to address issues related to proper recording of treatment information from varian machines.

Device

4D Integrated Treatment Console
  • Model / Serial
    4D ITC versions 8.1 SP2 to 10.0 SP1. See attachment for Serial numbers
  • Product Description
    Radiology information system (4DITC).
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • Manufacturer Parent Company (2017)
    Varian Medical Systems, Inc
  • Manufacturers representative
    Varian Medical Systems, Riyadh, (01) 2772126
  • Source
    SFDA