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 142 12 13 001
  • Event Initiated Date
    2014-01-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5117
  • 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
    A software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions. this issue may lead to image misinterpretation and/or inaccurate treatment decisions.

Device

PET Discovery 600 and Discovery 690 Systems.
  • Model / Serial
    PET Systems: (1) Discovery 600, (2) Discovery 690 Software Versions: pet_mict_plus.44; pet_velocity.53 ................. Health Canada update code : Discovery PET/CT 710 System Model or catalog No. : ( 5856030-X )
  • Product Description
    Scanning Systems, Computed Tomography/Positron Emission Tomography .
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare