Events

Retiro De Equipo (Recall) de Device Recall AGFA Computed Radiography system with NX2.X Workstations

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
    56158
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2100-2010
  • Fecha de inicio del evento
    2010-06-30
  • Fecha de publicación del evento
    2010-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92762
  • 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 MQB
  • Causa
    Monitor fell from the mounting bracket used to support the monitor.
  • Acción
    The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664. If you have any questions about this matter, please feel free to contact me via email at Debbie.norris@agfa.com or call me at 864-421-1754.

Device

Device Recall AGFA Computed Radiography system with NX2.X Workstations
  • Modelo / Serial
    LU8QJ000
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries of Puerto Rico and Canada.
  • Descripción del producto
    19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm || Agfa's Computed Radiography Systems with NX2.X software are indicated 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