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 003 06 11 000
  • Event Initiated Date
    2011-06-04
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=478
  • 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
    Due to an issue in the system time adjustment feature, the system time can drift. if unchecked, or not connected to a network time server, system time can drift, impacting standardized uptake value (suv) measurements. a fifteen minute difference between system time and the dose calibrator clock impacts suvs by 10%. discovery st systems without dimension consoles are not affected. no injury has been reported related to this issue.

Device

Positron Emission Tomography System
  • Model / Serial
    Discovery VCT, Discovery RX VCT, Discovery STE, Discovery RX and Discovery ST systems with Dimension console. Discovery ST systems without Dimension consoles are not affected.
  • Product Description
    Nuclear Medicine System, Positron Emission Tomography andX-ray System, Diagnostic, Computed Tomography, Full-body
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare