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 033 08 12 000
  • Event Initiated Date
    2012-08-14
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2190
  • 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
    While performing a fluoroscopic acquisition with the innova 2121iq or innova 3131iq systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. it may happen in a very specific scenario when one operator is requesting a lih (last image hold) functionality and another operator starts a short fluoroscopy exposure (stopping fluoroscopy exposure within 2 seconds) without waiting for the display of the lih (last image hold) in review monitor. the user would need to restart the system in order to regain acquisition capability. there can be an increased risk of complications during the procedure as a result of imaging functionality loss.

Device

Cardiovascular X-ray imaging systems, Innova 2121IQ, Innova 3131IQ
  • Model / Serial
    Innova 2121IQ, Innova 3131IQ
  • Product Description
    Cardiovascular X-ray imaging systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare