Events

Retiro De Equipo (Recall) de Device Recall Brilliance CT Big Bore Radiology

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
    71134
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1764-2015
  • Fecha de inicio del evento
    2015-03-06
  • Fecha de publicación del evento
    2015-06-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137650
  • 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 was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
  • Acción
    On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.

Device

Device Recall Brilliance CT Big Bore Radiology
  • Modelo / Serial
    Model #: 728244; Serial #s: 7486, 7510, 7514, 7525, 7529, 7533, 7538, 7543, 7544, 7546, 7557, 7570, 7571, 7572, 7575, 7576, 7583, 7586, 7587, 7594, 7595, 7600, 7604, 7607, 7610, 7614, 7619, 7621, 7625, 7631, 7632, 7636, 7651, 7653, 7654, 7660, 7668, 7669, 7670, 7676, 7683, 7686, 7688, 7692, 7694, 7697, 7708, 7710, 7711, 7712, 7713, 7714, 7717, 7719, 7721, 7722, 7723, 7732, 7733, 7734, 7738, 7742, 7746, 7747, 7756, 7760, 7764, 7766, 7767, 7771, 7772, 7773, 7778, 7780, 7781, 7789, 7790, 7798, 7804, 7809, 7813, 7819, 7825, 7826, 7830, 7839, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7943, 7952, 7957, 7958, 7959, 7964, 7967, 7979, 7981, 7986, 7988 & 7992.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Descripción del producto
    Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • 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