Events

Retiro De Equipo (Recall) de Device Recall Agfa IMPAX Cardiovascular

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 Healthcare 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
    77629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2652-2017
  • Fecha de inicio del evento
    2016-12-22
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156955
  • 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
    A customer experienced when using impax cv reporting software, specifically, when building a niv report, the niv cardio report was showing incorrect findings for aneurysm.
  • Acción
    AGFA Healthcare sent an Urgent Field Safety Notice dated December 22, 2016, to all affected consignees. The notice included an acknowledgement fax-back or email indicating that the information was received and understood. The notice informed the consignees of the problem and indicated that they would be contacted by Agfa Service to check the problem and to correct the NIV reporting clinical content. Customers with questions were instructed to call 1-401-330-7433. For questions regarding this recall call 864-421-1984.

Device

Device Recall Agfa IMPAX Cardiovascular
  • Modelo / Serial
    Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
  • Descripción del producto
    IMPAX Cardiovascular || The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • Dirección del fabricante
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • Empresa matriz del fabricante (2017)
    Agfa-Gevaert NV
  • Source
    USFDA