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 BrainLAB.

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 050 11 11 000
  • Event Initiated Date
    2011-11-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1024
  • 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 brainscan pencil beam dose algorithm may overestimate the dose delivered to the target region if both of the following conditions are met: - the scatter measurements have been performed according to the technical reference guide (trg) “brainlab physics” (any revision), i.E. the scatter table was measured and implemented without values for equal jaw and mlc field sizes. and - in the treatment plan, the margin between jaw position and mlc field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement.

Device

BrainSCAN ,Pencil Beam Dose Algorithm
  • Model / Serial
    Versions 5.31 and 5.32
  • Product Description
    Beam Dose Algorithm
  • Manufacturer
    BrainLAB

Manufacturer

BrainLAB
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01)2119948
  • Source
    SFDA