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 055 06 17 000
  • Event Initiated Date
    2017-06-15
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11185
  • 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 affected devices mentioned above have incorrect labelling with regard to the specified voltage for the alarm connectors on the rear side of the instrument. the current incorrect labels specify 125va.C. as maximum voltage. it has been identified, that if somebody connects such 125va.C. to the 6.3mm stereo jack, there would be hazardous voltage accessible on the plug which could lead in the worst case to a serious electrical incident.

Device

ASP6025 Tissue Processor
  • Model / Serial
    ASP6025 Tissue Processor Serial Numbers: 163, 169, 200-821, 823-895, 897-899, 901-1123 (all odd - serial numbers)
  • Product Description
    Tissue Processor
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Salehiya Trading Est.
  • Source
    SFDA