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 Draeger Medical Systems Inc.

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 082 04 12 000
  • Event Initiated Date
    2012-04-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1713
  • 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
    Regarding the pre-installation of a gas control unit, draeger noticed. they were not in the regulator function as the cartridge g40600 reduced in all cases with the required torque. when the cartridge is not used as specified, it may in extreme cases, cause the switch to the other supply side of your gas supply system is not functioning properly.

Device

Gas supply System, G40600
  • Model / Serial
    RE 1200 Basic and OM set KV with the serial numbers: ASCM-0511, ASCM-0512, ASCM-0507 installed between January, 2012 and March, 2012
  • Product Description
    Gas supply System
  • Manufacturer
    Draeger Medical Systems Inc

Manufacturer

Draeger Medical Systems Inc
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Manufacturers representative
    Draeger Arabia Co. Ltd.
  • Source
    SFDA