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 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 013 10 12 000
  • Event Initiated Date
    2012-10-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2458
  • 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
    A patient was mistreated after a user made and saved an inadvertent change to the definition of a treatment field in mosaiq. the field edit delta display feature is designed to minimize the risk of applying inadvertent changes to the treatment field definition form. it lists and/or highlights the changes to the treatment field definition form since the last approval or delivery of the associated treatment field. the field edit delta display feature was introduced in mosaiq version 2.00n2 as a configurable risk mitigation (i.E. shipped enabled, but users with appropriate permissions could disable it). the mistreatment occurred at a site that had disabled the feature. after the mistreatment, a risk re-assessment was completed. it was concluded that the risk outweighed any benefit of allowing users to disable the feature. the feature was made non-configurable (i.E. users cannot disable it) in mosaiq version 2.41.01e5.

Device

Radiotherapy software, MOSAIQ
  • Model / Serial
    Reference: CAR0271
  • Product Description
    Radiotherapy software
  • Manufacturer
    Elekta Inc

Manufacturer

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