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 Ascom.

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 095 07 12 000
  • Event Initiated Date
    2012-07-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2130
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    When assignments are changed for a location, the location conditions are stored in amemory cache; however, these entries are not deleted. eventually the memory cache becomes full which results in a module reboot. during this time, no information is communicated to any display devices.

Device

Monitoring, Ascom Mobile Monitoring Gateway (MMG)and Cardiomax
  • Model / Serial
    MMG, Mobile Monitoring Gateway and Cardiomax // Models MMG FE3-D1ABAA and FE3-D1ABAB resp. Cardiomax FE3-G1ABAB
  • Product Description
    Mobile Monitoring ,Alarm application software
  • Manufacturer
    Ascom

Manufacturer

Ascom