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 084 06 11 000
  • Event Initiated Date
    2011-06-22
  • Event Country
  • Event Source
    SFDA
  • Event Source URL
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The optical guidance platform (ogp) camera calibration is not designed or validated for durations longer than 24 hours. the ogp requires recalibration on a daily basis to ensure that the optical calibration is correct for proper patient alignment and monitoring before use in treatment.

Device

  • Model / Serial
    Software Version 2.6, 2.6.1 Serial numbers are Attached
  • Product Description
    Software, Radiotherapy System, Linear Accelerator
  • Manufacturer

Manufacturer

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