Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por STERIS Corporation.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 024 09 18 000
  • Fecha de inicio del evento
    2018-09-11
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13132
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    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
  • Modelo / Serial
    ORT 353C, ORT 353D and ORT 01G Orthopaedic Extensions distributed from January 20, 2016 through April 26, 2018.
  • Descripción del producto
    Orthopaedic Extensions
  • Manufacturer
    STERIS Corporation

Manufacturer

STERIS Corporation
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Representante del fabricante
    Al-Faisaliah Medical System
  • Source
    SFDA