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 Roche Diagnostics GmbH.

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 130 04 14 000
  • Event Initiated Date
    2014-04-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=5717
  • 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
    There is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start.

Device

Insulin Pumps, Accu-Chek Spirit Combo
  • Model / Serial
    Accu-Check Spirit Combo Insulin Pumps Serial Nos.: 10171897 through 10281629
  • Product Description
    Infusion Pumps, Insulin, Ambulatory
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (011) 4142200
  • Source
    SFDA