Retiro De Equipo (Recall) de Device Recall FOCAL Workstation

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
    Focal: the couch position can be moved between scans of the same ct study. when the images are imported into focal, the software is not checking the dicom image position (patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. a shift between image sets will exist of the same amount that the ct couch was moved.
  • Acción
    Elekta CMS Software sent an "ADVISORY NOTICE" dated January 19, 2009 to its affected customers. The notice identified the product, the problem, and the acton to be taken. Customers were informed that the workaround method available is to (use the image fusion feature already in Focal to relign the scans). The firm states that this issue is resolved in Focal version 4.62.00, which was released in March 2011. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.


  • Modelo / Serial
    Focal Release 4.40.00 and above
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singapore, Spain, and United Kingdom.
  • Descripción del producto
    Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. || Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
  • Manufacturer


  • Dirección del fabricante
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Empresa matriz del fabricante (2017)
  • Source