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 EOS Imaging.

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 072 06 17 000
  • Event Initiated Date
    2017-06-22
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11205
  • 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
    Eos imaging is initiating this medical device removal of the roth mobeli grab handles used with eos system. to date, eos imaging has received one complaint relating to the detachment of a grab handle located outside the gantry of the eos system and leading to the patient fall. the roth mobeli grab handles shall never be used outside the eos gantry to help the patient for standing up.

Device

ROTH MOBELI grab handles used with EOS System
  • Model / Serial
    • MOBELI Stabi Vario grab handle (ROTH catalogue number 14002 96 S - EOS imaging catalogue number 9000111773) • MOBELI Dual grip grab handle (ROTH catalogue number 14002 25 S – EOS imaging catalogue number 9000111774)
  • Product Description
    Radiographic Systems, Digital
  • Manufacturer
    EOS Imaging

Manufacturer

EOS Imaging
  • Manufacturer Parent Company (2017)
    EOS Imaging SA
  • Manufacturers representative
    Bio Standards
  • Source
    SFDA