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 136 04 13 001
  • Event Initiated Date
    2015-06-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7873
  • 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:
  • Reason
    Brainlab has detected that, when using the brainlab cranial navigation system, the following: may have a significant effect on the overall navigation accuracy: • large distance between reference array and region of interest • major changes of the camera position relative to the reference array during the procedure. those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure.

Device

Brainlab Cranial Navigation System
  • Model / Serial
    Brainlab Cranial Navigation System (all versions)
  • Product Classification
    Neurological Devices
  • Product Description
    Brainlab Cranial Navigation System
  • Manufacturer
    BrainLAB

Manufacturer

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