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
    58267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2407-2011
  • Fecha de inicio del evento
    2010-05-27
  • Fecha de publicación del evento
    2011-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98841
  • 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 software: for a specific clinical setup, the mlc leaf positions on the exported drr images might not match the mlc leaf positions displayed in xio.
  • Acción
    The firm, Elekta, issued an "important Safety Notice" undated, to its customers. The notice indicates the problem and the clinical impact. There is no reasonable workaround for this issue. The notice states a future XiO Release will resolve the issue and the customers will be notified when this solution is available. A return postcard was included with the mailing to verify consignee received the notice. For sites not returning the postcard within one month, the recalling firm will contact them via phone or email to confirm receipt of the notice. The customers were instructed to distribute this notice to any and all users of the CMS software at their organization who are potentially affected by this issue. If you have any questions, please call 314-993-0003 or 800-878-4267.

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