Retiro De Equipo (Recall) de 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Xio will underestimate the dose delivered when the closed leaf gap is set to 0mm on xio and a value other than 0mm is set on the accelerator.
  • Acción
    Computerized Medical Systems, Inc. sent an Important Safety Notice the week of April 30, 2012, by regional support managers via e-mail, fax, or regular mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. North American customers were instructed to go to, select the SupportPlus Login at the top of the page, enter their portal, select Downloads/Updates to download the latest patches. For Customers outside North America, go to, select the SOFTWARE button on the left, Treatment Planning Software, then Contact TPS Support tab, Download TPS Software Patches. ............................................................. Customers were also instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. For questions regarding this recall call 408-380-8023.


  • Modelo / Serial
    Versions 4.30.00, 4.31.00, 4.32.00, 4.33.00, 4.33.01, 4.33.02, 4.34.00, 4.34.01, 4.34.02, 4.40.00, 4.40.04, 4.40.05, 4.41.00, 4.41.01, 4.41.02, 4.42.00, 4.43.00, 4.44.01, 4.44.02, 4.44.03, 4.44.04, 4.45.00, 4.46.00, 4.46.01, 4.47.00, 4.50.00, 4.50.01, 4.50.02, 4.50.03, 4.50.04, 4.51.00, 4.51.01, 4.51.02, 4.60.00, 4.60.01, 4.61.00, 4.62.00, 4.62.01, 4.62.02, 4.62.03, 4.62.04, 4.62.05, 4.62.06, 4.63.00, and 4.64.00.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the country of Canada
  • Descripción del producto
    XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. || Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
  • Manufacturer


  • Dirección del fabricante
    Computerized Medical Systems Inc, 13723 Riverport Dr Ste 100, Maryland Heights MO 63043-4819
  • Empresa matriz del fabricante (2017)
  • Source