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 009 02 11 000
  • Event Initiated Date
    2011-02-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=110
  • 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
    Ge healthcare has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain brightspeed systems. if this event were to occur on your system, patient safety may be impacted.

Device

BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray System
  • Model / Serial
    BrightSpeed Excel Select, BrightSpeed Edge Select, BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4 distributed from October 2009 to December 2010. The software version is visible on the homepage of the service desktop.
  • Product Description
    CT Scanner System
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare