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 106 04 15 000
  • Event Initiated Date
    2015-04-23
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7524
  • 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 database deadlock could occur during the image acquisition process affecting the completeness of acquired images. while infrequent, database deadlocks do occur during normal database operations. there is the potential that one or more images may be missing from exams. no actual patient injuries have been reported.

Device

Centricity PACS-IW with Universal Viewer
  • Model / Serial
    Centricity PACS-IW with Universal Viewer versions: 5.0 through 5.0 SP5.1
  • Product Description
    an intuitive imaging application that connects advanced visualization, provides extensive breast imaging tools, image-enables EMR systems, and unlocks patient history from silos to better inform and streamline diagnosis.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare