Events

Retiro De Equipo (Recall) de Device Recall LATITUDE Patient Management System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Boston Scientific CRM Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57744
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2052-2011
  • Fecha de inicio del evento
    2011-01-10
  • Fecha de publicación del evento
    2011-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97300
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Causa
    Boston scientific has determined that data within certain printed reports obtained from the latitude patient management system may not be accurate, in that, the most recent presenting electrogram (mrp-egm) for some of the selected patients may be either missing or incorrect.
  • Acción
    Consignees were sent a Boston Scientific "LATITUDE¿ Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections.

Device

Device Recall LATITUDE Patient Management System
  • Modelo / Serial
    Software Versions 6.x versions launched on June 6, 2010 or later.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
  • Descripción del producto
    Boston Scientific's LATITUDE Patient Management System: || LATITUDE 6.1 Patient Management System Website || Server software, Model 6488 for United States || Server software, Model 6465 for European Union || LATITUDE 6.2 Patient Management System Website || Server software, Model 6441 for Canada || Server software, Model 6442 for Australia / New Zealand || Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Dirección del fabricante
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA