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
    58270
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2604-2011
  • Fecha de inicio del evento
    2010-05-19
  • Fecha de publicación del evento
    2011-06-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98844
  • 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
    Radiation Treatment Planning System - Product Code MUJ
  • Causa
    Xio software: when a treatment machine is defined in source file maintenance (sfm), the mlc model is set to elekta, and beams using this treatment machine are added to a new plan in teletherapy, xio automatically adds an mlc to the beam. this is because the elekta linac will always have an mlc in place when the plan is actually delivered.
  • Acción
    A Safety Notice, dated 5/20/10, was sent to Elekta / Computerized Medical Systems Inc clients in May 2010. The notice indicates the problem, the clinical impact. The notice states a future XiO Release will resolve the issue. A return postcard is included with the mailing to verify consignee received the notice. For sites not returning the postcard by 5/28/10, the recalling firm will contact them via phone or email to confirm receipt of the notice. The notice also informed the consignees they would be contacted when a solution was available.

Device

Device Recall XiO Radiation Treatment Planning System
  • Modelo / Serial
    XiO Release 4.50.00 and above
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil, Canada, Colombia, France, India, Ireland, Israel, Italy, Malaysia, Netherlands, Philippines, Poland, Spain, and United Kingdom.
  • Descripción del producto
    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
  • 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