Events

Retiro De Equipo (Recall) de Device Recall MOSAIQ

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
    68355
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1800-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-06-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127457
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    When using cma, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.
  • Acción
    Elekta sent an Important Safety Notice on May 23, 2014, to all affected customers. The notice identified the product the problem and the action needed to be taken by the customer. "Notify the affected customers of the issue - To be completed 06/22/2014 "Provide a fix to the defect in an expeditious timeframe. It is mandatory for all customers to apply the fix - Version 2.50.05 SP8 & Version 2.60 - To be released 05/16/2014 "Follow up with the affected customers for: -Confirmation receipt of the LIN, AND -Confirmation of installation of patch for the fix- To be completed 11/30/2014. For further questions please call (404) 993-5886.

Device

Device Recall MOSAIQ
  • Modelo / Serial
    N/A - Software versions 1.40 through 2.50, inclusive
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Honduras, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine and Venezuela.
  • Descripción del producto
    MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
  • 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