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 Olympus.

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 046 03 17 000
  • Event Initiated Date
    2017-03-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10780
  • 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
    The manufacturer of the shockpulse generator, cybersonics inc, produced the product in accordance with iec60601-1 standard, with an independent laboratory successfully certifying the system. however, more recent testing has identified that under certain conditions one of the test criteria (touch current under single fault condition) has the potential to exceed the standard.

Device

SPL-G – SHOCKPULSE GENERATOR
  • Model / Serial
    All serial numbers prior to CG0196 Serial numbers CG0201 - CG0204 All serial numbers starting DG
  • Product Description
    Lithotripsy System, Stone Eliminator
  • Manufacturer
    Olympus

Manufacturer

Olympus
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Manufacturers representative
    Salehiya Trading Est.
  • Source
    SFDA