Events

Retiro De Equipo (Recall) de Device Recall Focal Release 4.34.00 through 4.50.00 software

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
    58226
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2559-2011
  • Fecha de inicio del evento
    2009-06-12
  • Fecha de publicación del evento
    2011-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98748
  • 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
    Focal software: when a patient is defined as prone and the shifts are manually entered and the lock shift box is checked the x coordinate (left/right) and the z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). this could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.
  • Acción
    Computerized Medical System sent a CUSTOMER ADVISORY dated June 12, 2009, to all affected users. This advisory identified the product, the problem, and the action needed to be taken by the customer. There were no patients mistreated as a result of this issue The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403 ) 830-8023

Device

Device Recall Focal Release 4.34.00 through 4.50.00 software
  • Modelo / Serial
    Focal Release 4.34.00 through 4.50.00
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including Puerto Rico, and the countries of Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, Nicaragua, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, and Venezuela.
  • Descripción del producto
    Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. || 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
    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