Retiro De Equipo (Recall) de Device Recall Fresenius 2008T Hemodialysis Machine

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 Fresenius Medical Care Holdings, 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
    57851
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1526-2011
  • Fecha de inicio del evento
    2011-01-19
  • Fecha de publicación del evento
    2011-03-04
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-07-08
  • Fuente del evento
    USFDA
  • 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
  • Causa
    Cursor on the dialysis screen may disappear and not respond to user input.
  • Acción
    Fresenius Medical Care contacted customers by mailing a Customer Notification letter "Urgent correction FMNCA Model 2008T Hemodialysis Machine" via Certified-Mail, Return Receipt requested on January 19, 2011. The Technical Services department began contacting consignees by telephone on January 13, 2011, to schedule an appointment for installing the electronic board on the 2008T machines at the customers' facilities. For questions call Technical services 1-800-227-2572.

Device

  • Modelo / Serial
    Units distributed between Sept 1, 2010 and January 5, 2011. Serial 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  • Distribución
    Worldwide Distribution - USA and Canada
  • Descripción del producto
    Fresenius 2008T Hemodialysis Machine || Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS || Part Number 190713, 2008T Hemodialysis System with CDX || Part Number 190766, 2008T Hemodialysis System with biBag || The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA