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 Siemens Medical Solutions.

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 034 11 18 000
  • Event Initiated Date
    2018-11-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13477
  • 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
    The issue happens once images have been loaded and the user performed rotate and flip operations together and saved changes. when loading the images again, they are correctly flipped and rotated as per save but the orientation markers are incorrectly displayed. the error scenario does not happen when only one of either rotate or flip is performed.

Device

Image orientation labels with scenario.
  • Model / Serial
    Image orientation labels
  • Product Description
    Radiology picture archiving and communication system
  • Manufacturer
    Siemens Medical Solutions

Manufacturer

Siemens Medical Solutions
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    Siemens Medical Solutions, Riyadh, (01)277-8111
  • Source
    SFDA