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 STERIS 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 024 09 18 000
  • Event Initiated Date
    2018-09-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13132
  • 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
    Steris has identified that the welded connection between the main body of the ort 353c, ort 353d and ort 01g extension and the supporting bar may be incomplete; welding is only present on the top and underside instead of all around the connection point (affected components identified in red on the 3d images below). the incomplete weld may result in the component being weaker and subject to breakage when excessive downward force (exceeding 60kg) is applied. under normal use of the table and accessory, this amount of force is not expected to be applied; however, steris has received one report of component breakage during use related to the issue described above.

Device

ORT 353D, ORT 353C and ORT 01G Orthopaedic Extensions
  • Model / Serial
    ORT 353C, ORT 353D and ORT 01G Orthopaedic Extensions distributed from January 20, 2016 through April 26, 2018.
  • Product Description
    Orthopaedic Extensions
  • Manufacturer
    STERIS Corporation

Manufacturer

STERIS Corporation
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA