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 GE Healthcare.

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 029 03 11 000
  • Event Initiated Date
    2011-03-07
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=196
  • 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
    It has been discovered that when editing multiple reports of one or more patients in reporting tool, a special editing workflow can result in a report where some edited data from one patient/exam is saved into the report of another patient/exam. this even raises a safety issue due to a potential patients data mismatch concern.

Device

Advantage Workstation Reporting Tool, X-ray system
  • Model / Serial
    All Reporting Tool versions 2.5 or earlier on Advantage Workstation
  • Product Description
    X-ray system, computed tomography, application program software
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare