Events

Retiro De Equipo (Recall) de Device Recall Agfa IMPAX HeartStation ECG Management 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
    53604
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0366-2010
  • Fecha de inicio del evento
    2009-05-07
  • Fecha de publicación del evento
    2009-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85969
  • 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
    electrocardiograph - Product Code LLZ
  • Causa
    Heartstation does not refresh content changes to the pdf reports that are printed emailed or faxed from the index page. this may lead to a discrepancy in patient demographics between what is displayed in the heartstation client interface and the report delivered to the consumer. questions are being directed to the local agfa representative; the contact information was included in the letter.
  • Acción
    An Urgent Safety Notice was sent via FED-EX to all the sites with the affected units (a total of 6) on May 7, 2009. The three foreign accounts were notified by letter on May 14, 2009. The letter describes the potential issue and mitigation. Acknowledgment via FAX-Back that the information was received and understood was requested from the sites. Customers who use the print, email, fax functionality of this product were verbally notified of the defect and they have been advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the recommended workaround. The workaround is to only print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does not allow the user to print batches of reports as does the Index screen. Questions about this matter are being directed to the local Agfa HealthCare representative.

Device

Device Recall Agfa IMPAX HeartStation ECG Management System
  • Modelo / Serial
    Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
  • Descripción del producto
    AGFA IMPAX HeartStation ECG Management System.
  • Manufacturer
    AGFA Corp.

Manufacturer

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