Events

Retiro De Equipo (Recall) de Device Recall Agfa Healthcare Corp. NX 2008 Central Monitoring 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 AGFA 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
    52679
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1889-2009
  • Fecha de inicio del evento
    2009-06-22
  • Fecha de publicación del evento
    2009-09-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83625
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code LLZ
  • Causa
    After opening and closing a study on a central monitoring system while a study is still open on an in-room nx system, a problem of image mix-up can occur on the in-room nx system.
  • Acción
    An "Urgent Safety Notice" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.

Device

Device Recall Agfa Healthcare Corp. NX 2008 Central Monitoring System
  • Modelo / Serial
    NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
  • Descripción del producto
    NX 2008 Central Monitoring System (CMS). Product code: E2FB6 || Agfa's Computed Radiography Systems with NX Workstations are intended for use in || providing diagnostic quality images to aid the physician with diagnosis.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Dirección del fabricante
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA