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 109 09 13 000
  • Event Initiated Date
    2013-09-25
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4420
  • 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
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase-contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence, the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode), magnitude weighting mask is always on, and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Device

Imaging system software, CardiacVX and CardiacVX Flow
  • Model / Serial
    CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation
  • Product Description
    Analysis software running on Advantage Workstation.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare