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 116 01 17 000
  • Event Initiated Date
    2017-01-27
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10584
  • 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 recently become aware of a potential safety issue with the patient bore heating on the discovery mr450 narrow bore 1.5t mri. in the event of a rf component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. if this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.

Device

Discovery MR450 narrow bore 1.5T MRI
  • Model / Serial
    Discovery MR450, narrow bore 1.5T non-GEM. Distribution dates: June 2009 through July 2016.
  • Product Description
    MRI Coil
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare