Events

Retiro De Equipo (Recall) de Device Recall Focal Radiation Treatment Planning 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 Computerized Medical Systems Inc.

¿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
    58256
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2596-2011
  • Fecha de inicio del evento
    2007-11-30
  • Fecha de publicación del evento
    2011-06-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98822
  • 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, planning, radiation therapy treatment - Product Code MUJ
  • Causa
    Focal: when a plan is sent to focal from xio and the structure properties are edited in focal ct sim activity, these changes result in changes to the mlc or field size for the plan when they should not. xio will recalculate dose when modified plan is returned to xio however the user may not notice that it has changed form the plant they had approved earlier. editing the structure properties (col.
  • Acción
    Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.

Device

Device Recall Focal Radiation Treatment Planning System
  • Modelo / Serial
    Focal Release 4.3.0 through 4.34.01
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (Nationwide AL, AR, CA, DE, FL, GA, IL, IN, MA, MD, MI, MOP, NE, NY, OH, PA, RI, TX, VA, WA, WI, and WV and the countries of Albania, Argentina, Belgium, Bosnia and Herzegovina, Brazil, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Turkey, United Kingdom, Uruguay, and Venezuela.
  • Descripción del producto
    Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 || For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Dirección del fabricante
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA