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 021 06 18 000
  • Event Initiated Date
    2018-06-07
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12724
  • 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
    Recently three (3) complaints were reported involving mechanical part failures for the leica m320 microscope system. these specific systems had failures with the screws that hold the gas spring fixation bracket in place. due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. this may potentially cause the m320 optics carrier to drop to the lower mechanical end stop.

Device

M320 Microscope System
  • Model / Serial
    M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 manufactured between May 18th, 2014 and January 21st, 2015.
  • Product Description
    Microscope System
  • Manufacturer
    Leica Microsystems Inc.

Manufacturer

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