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 054 03 13 000
  • Event Initiated Date
    2013-03-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3249
  • 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
    Potential malfunction may occur randomly after system installation or software upgrade to artis vc20x/vc21a/vd10x. if the operator has moved the system (stand or table) between dsa taken and dsa used as mask when executing the ogp roadmap in the dsa overlay mode, the image visualizing the vessel tree and the roadmap image visualizing devices such as a catheter may not be registered precisely when displayed on the live monitor.

Device

Stationary angiographic x-ray system, digital
  • Model / Serial
    Software Artis: VC20x/VC21A/VD10x
  • Product Description
    X-ray system, digital
  • 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