Events

Retiro De Equipo (Recall) de 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 Elekta, 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
    68984
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2574-2014
  • Fecha de inicio del evento
    2014-08-18
  • Fecha de publicación del evento
    2014-09-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129201
  • 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
    When dicom is exporting an arc plan (vmat, dynamic conformal of 3d static arcs) and using the composite field sequencing (cfs) feature, the dicom exported plan will not match the approved treatment plan.
  • Acción
    Elekta, Inc. issued an Urgent Important Field Safety Notice letter (IFSN 382-01-MON-001) to all affected customers.. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in a patch to Focal 4.80. Development is underway with a release date of September 2014 with confirmation of installation of the patch for the fix no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers (FCO: 382-01-MON-001 VID:2.0). For questions contact your local Elekta office.

Device

FOCAL Workstation
  • Modelo / Serial
    Software versions 4.70.00 & 4.80.00
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech republic, Ecuador, Egypt, Estonia, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Pakistan Portugal, Romania, Russia, Saudi Arabia, Singapore, Solvenia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom
  • Descripción del producto
    FOCAL Sim Workstation, Radiation Treatment Planning System. || Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA