Retiro De Equipo (Recall) de Device Recall Synergy xray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVI

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
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Potential collision risk when using xvi and external beam shaping devices.
  • Acción
    Elekta sent an Important Field Safety Notice dated November 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Corrective Action #1 - Potential collision risk when using XVI and external beam shaping devices. (Only software version R4.2.1 from this notice are applicable to this recall). Recommendations to Users - Monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the FKP. To correct the error - (1) Restart XVI. (2) Put the patient in their initial setup position. (3) Scan the patient again, and continue the usual workflow. Always monitor the patient when do RATM. When you do Volume View acquisitions with the Apex collimator attached, make sure that the stop angle of the Volume View parameters is in the lower half of the gantry rotation. This decreases the risk of a collision with the patient. Read and follow the advice in the Important Field Safety Notice (200 01 507 081) and acknowledge receipt to your Elekta representative within 30 days. Corrective Action #2 -Permanent Solution - XVI Risk control measure - changes to the software to prevent table movement if the start position has not been recorded correctly. Recommendations for changes to product are - (1) Table zero should default to NIHII not zero. (2) Check that the table zero is valid because calculating absolute table positions. (3) Check prescribed table position is not more than 2.5cm from actual table position when permitting ASU from outside room. Target Release XVI R.4.2.2 estimated for release April 2014. For further questions please call (770) 300-9725.


  • Modelo / Serial
    Model 4.2.1
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.
  • Descripción del producto
    Synergy XVI || The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer


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