Retiro De Equipo (Recall) de Synergy XVI kV Generator

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
    A small number of sites have experienced situations with kv generator transformers overheating due to a diode failure on the interface board.
  • Acción
    The firm, Elekta, issued a "FIELD CHANGE ORDER MANDATORY ACTION" notice dated October 20, 2011 to its customers to add fuse protection for the kV transformers. The notice describes the product, problem, provides instructions and procedures and actions to be taken. The customers were instructed to follow any instructions or recommendations covered in the notice and to file the document in the Important Notice section of the appropriate User Manual. Elekta will contact the customer if the FCO is applicable to their kV generator. If you have any questions, call 770-300-9725.


  • Modelo / Serial
    G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution: USA including states of: AL, AK, AZ, CA, CT, FL, GA, IL, IA, KY, MD, MS, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TX, VT, VA, WA, WV, WI, Puerto Rico, & DC.
  • Descripción del producto
    Elekta Synergy XVI X-ray Volume Imaging System || To be used as part of radiation therapy treatment process.
  • Manufacturer


  • Dirección del fabricante
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Empresa matriz del fabricante (2017)
  • Source