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 Arcomed AG.

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 156 03 18 000
  • Event Initiated Date
    2018-03-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12380
  • 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
    Arcomed ag has been informed that in some rare cases the syramed μsp6000 and volumed μvp7000 would signal a safety alarm. during the alarm the devices stop the infusion until restarted by the user. some reports indicate that on some pumps the display of the time and date was not correct. this is only an informative display and has no influence on the function of the pump.

Device

Syramed μSP6000 and Volumed μVP7000
  • Model / Serial
    Syramed μSP6000 and Volumed μVP7000
  • Product Description
    Infusion Systems
  • Manufacturer
    Arcomed AG

Manufacturer

Arcomed AG