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 St. Jude Medical Inc..

¿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 005 09 17 003
  • Fecha de inicio del evento
    2017-11-19
  • 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=11764
  • 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: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158781
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to st. jude pacemakers that utilize radio frequency (rf) communications (i.E., accent™/ anthem™, accent mri™/ accent st™, assurity™/ allure™ and assurity mri™). this firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack.

Device

Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices
  • Modelo / Serial
    Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices …………………………. FDA update codes: - Please Check attached file for update codes -
  • Descripción del producto
    Pacemaker
  • Manufacturer
    St. Jude Medical Inc.

Manufacturer

St. Jude Medical Inc.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Representante del fabricante
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA