Events

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
    Recall
  • ID del evento
    58197
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2579-2011
  • Fecha de inicio del evento
    2010-10-03
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98664
  • 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: when the beam template is recalled, xio prematurely initiates a dose calculation, re-snaps the mlc or port to the structure of the current patient , but then fails to re-calculate dose for the new mlc or port position. if no subsequent change is made to force a dose recalculation, xio will display the dose from the original mlc/port shape dose instead of the dose from the re-snapped mlc/port.
  • Acción
    The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice. The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

Device

XiO Radiation Treatment Planning System
  • Modelo / Serial
    XiO Release 4.30. and above
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • Descripción del producto
    XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above || Used to create treatment plans for any cancer patient for who 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