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 Elekta Limited.

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 119 12 14 001
  • Event Initiated Date
    2015-03-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7282
  • 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: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133680
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Incorrect ct to ed when using monaco image statistics tool.

Device

Monaco, Radiotherapy
  • Model / Serial
    Sites affected will be those meeting ALL three criteria below: 1- Running Monaco Release 3.30 and higher 2- Using a CT Slice Spacing not equal to the CT Slice Thickness 3- Using the Image Statistics Tool to quantify CT phantom densities which are then used to populate the CT to ED file. ................. FDA update code : Focal Sim, Focal Release 4.80
  • Product Description
    Radiotherapy, planning and verification systems software
  • Manufacturer
    Elekta Limited

Manufacturer

Elekta Limited
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Manufacturers representative
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA