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 Schiller 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 048 01 16 000
  • Event Initiated Date
    2016-01-13
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8770
  • 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
    Your fred easy is equipped with an internal battery, independent of the main battery (blue), which must be replaced every six years. this is described in the user guide, in the section "maintenance". the replacement of this battery every 6 years is compulsory, the proper function of your device depends of it. if this instruction is not observed, the device could become unable to start. this requires the intervention of qualified personnel, the disassembly is required.

Device

FRED easy
  • Model / Serial
    Begins the serial number of your FRED easy with 58xxxxxx (8 digits) or is your Serial number 058xx7)0000cx, 058xx8xx)ocxx, 058xx9xxxxxx (12 digits)
  • Product Description
    Defibrillator
  • Manufacturer
    Schiller AG

Manufacturer

Schiller AG
  • Manufacturer Parent Company (2017)
    Schiller Holding Ag
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA