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 087 07 13 000
  • Event Initiated Date
    2013-07-14
  • Event Country
  • Event Source
    SFDA
  • Event Source URL
  • 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
    May exhibit various out-of-context problems. safety issue : ( description, affected products details); safety issue #1 : ( in centricity ris-ic, and a ris-driven integration, the “close” button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation, centricity pacs versions 3.2.2.3 and forward are affected ); safety issue #2 : ( interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation, centricity pacs versions 3.2 and forward are affected ); safety issue #3 : ( interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation, centricity pacs versions 3.1.1.2 and forward are affected ); safety issue #4 : ( centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag, centricity pacs versions 2.X and forward).

Device

  • Model / Serial
    Centricity PACS versions ( 2.1.5.6; 2.1.5.8; 2.1.5.9; 2.1.5.10; 2.1.5.11; 2.1.5.13; 3.1.1.2; 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 4.0; 4.0.1 )
  • Product Description
    Workstations, Picture Archiving and Communication System
  • Manufacturer

Manufacturer