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 049 12 11 000
  • Event Initiated Date
    2011-12-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1152
  • 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
    May display incorrect patient name on images (volume viewer) or tabs (results viewer). issue 1: on monitors with 2 megapixel (2mp) resolution, switching between two volume viewer tabs with different patients, the topmost strip of the volume viewer display fails to update between patients. issue 2: when starting the results viewer application in the aws client window for a particular patient exam, if a second patient exam is selected while the application is starting, the results viewer will display the second patient’s image data and name in the viewports; however, the first patient name will display on the applications tab.

Device

Workstations, Radiotherapy, Planning. Advantage Workstation Servers
  • Model / Serial
    Advantage Workstation Servers (AWS): Software Version 2.0; Release Version 2.0-4.0
  • Product Description
    Workstations, Radiotherapy, Planning
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare