Events

Retiro De Equipo (Recall) de Device Recall Results Management (RM) Reporting Module

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
    60154
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0211-2012
  • Fecha de inicio del evento
    2011-06-06
  • Fecha de publicación del evento
    2011-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104617
  • 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
    Improper merging of impax cardiovascular results management (rm) reports causes the signed report to become unavailable.
  • Acción
    AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 27, 2011, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to carry out a merge post finalization of an RM reports. If it is necessary to modify a finalized report, AGFA recommends that they make the modification through one of the following actions: Amend the report through the RM interface, or Call AGFA Service to change the status of the report to "preliminary" and then proceed with the finalization of the report. AGFA issued an Acknowledgment, via FAX- Back that the information was received and understood to affected customers. For any questions customers were instructed to contact their AGFA Healthcare Service at 877-777-2432.

Device

Device Recall Results Management (RM) Reporting Module
  • Modelo / Serial
    Software Versions: RM2.04.37.04 to RM 7.8 SU2 (RM 2.04.37.04 is a version prior to CV 7.2 release).
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Canada
  • Descripción del producto
    IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 || The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and 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