Retiro De Equipo (Recall) de Device Recall Terumo Advanced Perfusion System 1

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 Terumo Cardiovascular Systems Corporation.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Terumo cvs has received reports of the central control monitor (ccm) for terumo advanced perfusion system 1 losing partial or full functionality. symptoms that have been associated with a malfunctioning ccm include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the ccm.
  • Acción
    The firm, TERUMO, sent an "URGENT MEDICAL DEVICE RECALL" notice dated June 22, 2012 and addendum to the Operator's Manual via Federal Express to its customers. The letter described the product, problem and actions to be taken. The notice states to the customers "Please note that we are not recommending that you stop using your Central Control Monitor". The customers were instructed to review the Medical Device Recall notice; assure that all users are aware of this notice; place the Addendum at the beginning of the Central Control Monitor Section (page 4-1) of the Operator's Manual and complete and return the attached Customer Response Form to the fax number indicated on the form. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours are from Monday-Friday, 8 AM - 6 PM ET.


  • Modelo / Serial
    Catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313- 0322,1001-1027, 1100-1434, 1436, 1440, and 1441.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), and Vietnam.
  • Descripción del producto
    Central Control Module for System 1: System 1 Base, 220/240V || The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • Manufacturer


  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
  • Source