Retiro De Equipo (Recall) de Brilliance iCT SP

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 Philips Medical Systems (Cleveland) 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
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    Software issues found in v4.1 .3/4.1.5 in the philips brilliance ict/ ict sp products that could affect the performance of the equipment.
  • Acción
    The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.


  • Modelo / Serial
    Brilliance iCT SP Model No. 728311  S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032, 200030,200043,200040,200038,200047,200051,200044,200063,200061,200068,200067, 200089,200088,200092,200093,200101,200097,200100,200105,200109,200121,200204, 200111,200117,200127,200131,200200,200205,200138,200202,200201,200203,200209, 200210,200206,200208,200207,200211,200019,200015,200029,200024,200023,200025, 200026,200041,200086,200102,200213
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • Descripción del producto
    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
  • Manufacturer


  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
  • Source