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 FUJIFILM Corporation.

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 098 02 18 000
  • Event Initiated Date
    2018-02-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12175
  • 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 field corrective safety action for the ed-530xt includes replacement of the forceps elevator mechanism and o-ring seal, replacement of the distal end cap, and new operation manuals. the updated design and labeling were implemented in an abundance of caution to help reduce the potential risk to health that may be associated with inadequate reprocessing of the device.

Device

Duodenoscope Model ED-530XT

Manufacturer

FUJIFILM Corporation
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA