Events

Retiro De Equipo (Recall) de Device Recall Alaris

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 CareFusion 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
    Recall
  • ID del evento
    70608
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1311-2015
  • Fecha de inicio del evento
    2015-03-12
  • Fecha de publicación del evento
    2015-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134153
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    Carefusion is recalling the alaris pc unit because of an error code. the error code may occur upon power on during the "power-on self test" due to a keypad issue.
  • Acción
    CareFusion sent an Urgent: Medical Device Recall Notification letter dated March 12, 2015, to all affected customers. The letter informs the customers that CareFusion has received service reports of a system error on the Alaris PC unit 8015. The letter informs customers of the problems identified and the actions to be taken. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, DL-US-INF-TechSupport@carefusion.com.

Device

Device Recall Alaris
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and worldwide to: Canada, Netherlands, New Zealand and Singapore
  • Descripción del producto
    CareFusion Alaris PC Unit Model 8015 (formerly Medley || PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December || 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
  • Manufacturer
    CareFusion Corporation

Manufacturer

CareFusion Corporation
  • Dirección del fabricante
    CareFusion Corporation, 10020 Pacific Mesa Blvd, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA