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
    57807
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2582-2011
  • Fecha de inicio del evento
    2010-11-16
  • Fecha de publicación del evento
    2011-06-17
  • 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=97479
  • 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 a new electron beam is added to a plan, the calculation algorithm is set to pencil beam, and an aperture is added to the beam, the user can select port-port properties and edit the material thickness values. if the algorithm is then changed to monte carlo, the calculation will proceed and the user is not warned the material/thickness values just entered are not used in the dose calculati.
  • Acción
    Elekta CMS Software drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was distributed to all affected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be available in July 2011.

Device

Device Recall XiO Radiation Treatment Planning System
  • Modelo / Serial
    Release 4.50 and higher
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam
  • Descripción del producto
    XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above || Used to create treatment plans for any cancer patient for who external beam radiation therapy of 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