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 146 08 13 000
  • Event Initiated Date
    2013-08-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4244
  • 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 due to exposed yellow foam on the end bells of discovery mr450, discovery mr750, and optima mr450w products. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.

Device

Magnetic Resonance Systems, Discovery MR450, Discovery MR750, and Optima MR450w
  • Model / Serial
    All Discovery MR450, Discovery MR750, and Optima MR450w products.
  • Product Description
    Magnetic Resonance Systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare