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 060 06 12 000
  • Event Initiated Date
    2012-06-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1918
  • 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
    The axial and coronal reformatted images from a sagittal 3d series (such as with applications of fspgr-3d t1, bravo t1, or cube t1) of over 126 slices may display a left-to-right image flip . in addition, the acquired sagittal images may be annotated with left-right location annotation reversed. this issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.

Device

MRI, Signa and Discovery
  • Model / Serial
    Discovery MR450, Optima MR450w (with and without GEM), Discovery MR750, Optima MR360, Brivo MR355, Signa HDx, Signa HDxt, Signa Vibrant, Signa HDi, Signa HDe 1.5T, Ovation HD, and Profile HD
  • Product Description
    MRI, scanner, Full Body
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare