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 Leica Microsystems 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 098 01 16 000
  • Event Initiated Date
    2016-01-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8824
  • 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
    An electronic component in one of the two illumination units can potentially overheat, resulting in minimal smoke and odor emanating from the ventilation openings of the illumination units.

Device

Leica M525 OH4 and Leica M720 OH5
  • Model / Serial
    Leica OH4/ OH5 Surgical Microscope Stands with 400W illumination manufactured from 1st October 2012 until 1st September 2014 Multiple serial numbers affected
  • Product Description
    Surgical microscope systems
  • Manufacturer
    Leica Microsystems Inc.

Manufacturer

Leica Microsystems Inc.
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA