Events

Retiro De Equipo (Recall) de Device Recall CRS

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
    57821
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1434-2011
  • Fecha de inicio del evento
    2011-01-27
  • Fecha de publicación del evento
    2011-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97506
  • 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
    System, image processing, radiological - Product Code LLZ
  • Causa
    Echocardiography volume measurements performed within crs were not reflected correctly in associated results management (rm) reports.
  • Acción
    The firm, AGFA Healthcare, sent a "Safety Notice" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to debbie.norris@agfa.com. Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades. If you have any questions about this matter, please contact the Post Market/QARA North America via email at debbie.norris@agfa.com or call at 864-421-1754.

Device

Device Recall CRS
  • Modelo / Serial
    Software Versions 2.12.05 - 2.14.03.SU1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and country of: Canada
  • Descripción del producto
    Cardiovascular Review Station || The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.
  • Manufacturer
    AGFA Corp.

Manufacturer

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