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 097 08 18 000
  • Event Initiated Date
    2018-08-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13095
  • 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
    Leica microsystems received five customer complaints stating that users inadvertently tipped over their leica m525 f20 microscope system. in four cases it was confirmed, that the issue occurred when users handled the microscope while the swing arm was in fully extended position (see figure 3 in the attached fsn). in all cases the leica m525 f20 did not cause or contribute to serious injury. the five complaints occurred in five different countries over a timeframe between the years 2010 and 2017. the leica m525 f20 was introduced in the year 2009 with more than 1000 instruments distributed globally up to date.

Device

Leica M525 F20
  • Model / Serial
    All Leica M525 F20 Microscope Systems
  • Product Description
    Microscopes, Light, Operating
  • Manufacturer
    Leica Microsystems Inc.

Manufacturer

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