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 Mortara Instrument, 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 083 10 14 000
  • Event Initiated Date
    2014-10-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6606
  • 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
    A hazardous situation may be created when mounting these monitors using the 75mm vesa mounting hole pattern provided in the battery cover of these monitors.

Device

Mortara Surveyor S12 and Surveyor S19 Patient Monitors
  • Model / Serial
    Product Name : SURVEYOR Mortara Part Number : SUR12-BCF-AXXAD Device Serial Number : 114170207572 Product Name : SURVEYOR Mortara Part Number : SUR19-BCF-AXXAC Device Serial Number : 114170207577
  • Product Description
    Patient Monitor
  • Manufacturer
    Mortara Instrument, Inc.

Manufacturer

Mortara Instrument, Inc.
  • Manufacturer Parent Company (2017)
    Mortara Instrument, Inc
  • Manufacturers representative
    Saudi Health Services Co. Ltd.
  • Source
    SFDA