Events

Retiro De Equipo (Recall) de Device Recall Focal Radiation Treatment Planning 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
    Recall
  • ID del evento
    57845
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2562-2011
  • Fecha de inicio del evento
    2010-11-09
  • Fecha de publicación del evento
    2011-06-14
  • 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=97560
  • 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: if a plan involving dynamic mlc delivery is sent from xio to focal and called up there in plan review, the angle of the gantry is set to zero for all beams. if this plan is then sent from focal to the r&v; system, the gantry angles all remain at zero which could lead to patient mistreatment.
  • Acción
    Elekta CMS Software sent a USER NOTICE dated November 5, 2010, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends to correct the software so it does not modify anything about the plan sent from XiO. Customers were instructed to contact their local customer support office with any questions.

Device

Device Recall Focal Radiation Treatment Planning Workstation
  • Modelo / Serial
    Release 4.51.00 and higher
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Singapore, Slovenia, South Africa, Spain, Suriname, Switzerland, Taiwan, Turkey, Turkmenistan, and the United Kingdom.
  • Descripción del producto
    Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. || 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 form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods.
  • 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