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 078 05 11 000
  • Event Initiated Date
    2011-05-25
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=440
  • 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
    When using the summary table feature on thoracic vcar to display data, incorrect patient name will be displayed if the user does not exit the application in between the analysis of two consecutive patients. this only affects the summary table information, whereas the individual dicom information and actual data itself is not affected and the data integrity is intact.

Device

Thoracic VCAR application software on Advantage Workstation
  • Model / Serial
    Thoracic VCAR versions 9.3 through 9.6.24 are affected.
  • Product Description
    X-ray system, diagnostic, computed tomography, application program software
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare