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 012 05 11 000
  • Event Initiated Date
    2011-05-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=374
  • 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 that in the event of a significant power surge, such as one that might be caused by a lightning strike or a utility equipment failure; there is a possibility that the fuse in the mru (magnet rundown unit) circuit could be affected. this situation could indirectly lead to a potential hazard if an emergency magnet quench is required.

Device

Magnetic Resonance Systems
  • Model / Serial
    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx. Signa HDxt, Signa HFO, GE 1.5T Signa HDe, GE 1.5T Signa HDsv, Signa Excite 1.5T & 3T All MRU units (5196918) shipped to the field between October/01/2009 – December/10/2010 will be included in the fix.
  • Product Description
    The involved systems are whole body magnetic resonance scanners designed to support high resolution and high signal-to-noise ratio images in short exam times. They are indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare