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 057 04 12 000
  • Event Initiated Date
    2012-04-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1688
  • 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 fmri protocol in ready view, the ready view application may incorrectly sort the phases of the fmri native data set. this happens when the fmri data was acquired using the brainwave rt acquisition scheme on the mr console. no adverse event has been reported related to this issue. this affects the analysis of the image set made by the correlation algorithm used in the fmri protocol. as a result, activated pixels identified as having a high correlation with a reference pattern may not be correctly identified.

Device

Workstation software, READY View
  • Model / Serial
    READY View version 10.3.67 is affected; PR# 7130256 to AFSSAPS (reference 201205472)
  • Product Description
    Workstation software, analyzing fMRI images
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare