Events

Retiro De Equipo (Recall) de Device Recall XiO 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
    59102
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2919-2011
  • Fecha de inicio del evento
    2011-06-09
  • Fecha de publicación del evento
    2011-08-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101149
  • 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
    The xio software currently prompts for entry of ct to ed data for a studyset. no indication is given that the electron density data should only be used for photon and electron calculations and either relative stopping power or mass density should be used for proton calculations (depending on the algorithm).
  • Acción
    The firm, Eletka, Inc., issued an "Important Safety Notice" dated May 18, 2011 via mail to all affected sites. The notice explains the issue and identifies a work around to the problem until the new release is available. The customers were instructed to complete and return the enclosed "Confirmation of Receipt" form via FAX to 314-993-1175, attn: QA; e-mail or mail: CMS Software, Attn: QA, 13723 Riverport Drive, Suite 100, Maryland Heights, MO 63043. The notice states that "this problem has existed since XiO Release 2.4.0 and has been resolved in XiO Release 4.63.0 by adding warning messages and explanations to the XiO On-Line Help. Your site will be notified when this release is available." If you have any question, call 314-993-0003, 800-878-4267 or 408-830-8023.

Device

Device Recall XiO Radiation Treatment Planning System
  • Modelo / Serial
    XiO versions equal to or greater than 2.4.0 and less than 4.63.0
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including: IL, IN, MA, NJ and OK; and country of Germany.
  • Descripción del producto
    XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 || The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
  • 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