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 Smith & Nephew.

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 037 01 17 000
  • Event Initiated Date
    2017-01-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10499
  • 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 distributed operator manual includes incorrect electromagnetic emission classifications. the radiated emission (cispr 11) should be class a instead of class b; harmonic emission (iec 61000-3-2) should be, not applicable opposed to class b. the voltage fluctuations/flicker emissions (iec 61000-3-3) should have also been classified as not applicable.

Device

HD1200 AUTOCLAVABLE CAMERA HEAD AND HD1200 AUTOCLAVABLE CAMERA CONTROL UNITS
  • Model / Serial
    Product No.: (Description) - 72203360 : ( HD1200 AUTOCLAVABLE CAMERA HEAD) - 72203361: ( HD1200 AUTOCLAVABLE CAMERA CONTROL UNIT) - All Serial Numbers - July 2011 through September 2016
  • Product Description
    Autoclavable Camera System
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew