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 Medical Systems..

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 033 01 11 000
  • Event Initiated Date
    2011-01-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=48
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    1. when using the center on cursor feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr will move to a position where the 3d cursor is centered on the screen. 2. when using the isocenter move mode feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr is correctly recalculated and shown. 3. when the image series is changed (on the top left corner of a drr view) while using drr blending, the captured drr is not recalculated or cancelled. 4. when using the blended drr function the visualization of the captured drr may change without the visualization parameters (mixing and depth control) being updated on-screen after choosing a drr preset for the active drr. 5. when a new beam is created after using drr blending on a previous beam, switching back to the previous beam may cause annotations for blending, mixing and depth control to not be shown.

Device

Advantage Sim MD.
  • Model / Serial
    Software version: 5.x, 6.x, 7.x
  • Product Description
    Software for X-ray system, used for radiotherapy.
  • Manufacturer
    GE Medical Systems.

Manufacturer

GE Medical Systems.
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Manufacturers representative
    GE Healthcare., Riyadh, (01) 4600530
  • Source
    SFDA