Events

Retiro De Equipo (Recall) de Device Recall "NX" Modality Workstation

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
    58166
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2137-2011
  • Fecha de inicio del evento
    2011-03-04
  • Fecha de publicación del evento
    2011-05-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98571
  • 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
    NX - Image Acquisition and Processing Station - Product Code MQB
  • Causa
    When a radiographer is working on two open studies on an nx workstation and, in specific situations, a problem of image/annotation mix-up can occur on the nx system.
  • Acción
    AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815.

Device

Device Recall "NX" Modality Workstation
  • Modelo / Serial
    Software Versions: 2.0.8100, 3.0.8100, 2.0.8200, 3.0.8200, 2.0.8300, 3.0.8300, 2.0.8400, 3.0.8400, 2.0.8500, and 3.0.8500
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada
  • Descripción del producto
    NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.
  • Manufacturer
    AGFA Corp.

Manufacturer

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