Events

Retiro De Equipo (Recall) de Brilliance 64 Computed Tomography Xray systems

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
    Recall
  • ID del evento
    72282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0174-2016
  • Fecha de inicio del evento
    2015-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140468
  • 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
    The firm discovered ring/dot artifact due to x-ray measurement error.
  • Acción
    On 9-23-2015 the firm sent URGENT Field Safety Notices to their customers. The letter identified the products, problem, and actions to be taken by the customers.

Device

Brilliance 64 Computed Tomography Xray systems
  • Modelo / Serial
    Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 9999, 10009, 10066, 10196, 10804, 10807, 29009, 29039, 29047, 29049, 29051, 29070, 29135, 29151, 90035, 90056, 90069, 90085, 90156, 90189, 90192, 95054, 95120, 95138, 95164, 95259, 95285, 95345, 95350, 95359, 95403, 95441, 95442, 95470, 95480, 95497, 95498, 95502, 95517, 95521, 95522, 95561, 95633, 95643, 95656, 95695, 95884, 95885, 95886, 95889, 95893, 95894, 95896, 95897, 95898, 95899, 95900, 95901, 95902, 95903, 95904, 95905, 95906, 95907, 95908, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95916, 95917, 95918, 95919, 95920, 95921, 95922, 95923, 95924, 95925, 95926, 95927, 95928, 95929, 95930, 95931, 95933, 95934, 95936, 95937, 95938, 95940, 95941, 95942, 95944 & 95946.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • Descripción del producto
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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