Events

Retiro De Equipo (Recall) de Stockert S5/Sorin C5 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 Sorin Group USA, Inc..

¿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
    63383
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0275-2013
  • Fecha de inicio del evento
    2012-09-19
  • Fecha de publicación del evento
    2012-11-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114403
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Causa
    Sorin group usa, inc. has issued an urgent field safety notice regarding certain serial numbers of the sorin group s5 perfusion system due to reports of a "fault in motor controller" alarm message displayed on the system panel. this could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. an out of specification electrical component was determin.
  • Acción
    The firm, Sorin Group, sent an "URGENT FIELD SAFETY NOTICE" dated September 19, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. The customers were instructed to follow the provided instructions for the continued safe use of the Perfusion systems until they have been serviced or replaced by Sorin Group. The Sorin Group Service Team will contact the customer to schedule servicing and replacement of the affected product. The customers were also instructed to complete and return the Customer Response Form via fax to 303-467-6502 or by email to yvonne.feyerherm@sorin.com; assure this notice is distributed to all personnel who need to be aware of this notice; and if they have transferred the affected products to a third party, pass this information with them as well as with Sorin Group Customer Service at 1-800-650-2623. For questions regarding this notice, contact Sorin Group USA Customer Service at 1-800-650-2623.

Device

Stockert S5/Sorin C5 System
  • Modelo / Serial
    Serial Numbers: 58E00135; 58E00136
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.
  • Descripción del producto
    Sorin C5 Perfusion System, Item number 58-00-00 || The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Dirección del fabricante
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA