Events

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

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
    71124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2255-2015
  • Fecha de inicio del evento
    2015-02-05
  • Fecha de publicación del evento
    2015-07-24
  • 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=138615
  • 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
    5 issues. fast get ready incorrectly enabled during service procedures. contrast annotation missing for some images when manual contrast was administered. dot artifact present, intermittently, after startup. heart rate measured value incorrectly remains constant for some heart rate change conditions. doseright incorrectly enabled when the exam card specified disabling doseright. tube heat predict.
  • Acción
    On 2/5/2015 the firm sent Customer Information Letters to their customers.

Device

Device Recall Computed Tomography Xray systems Brilliance iCT
  • Modelo / Serial
    Brilliance iCT: Model #728306; Serial #s: 85012, 85013, 85014, 100029, 100038, 100040, 100053, 100058, 100094, 100099, 100133, 100140, 100162, 100178, 100236, 100244, 100373, 100399, 100408, 100411, 100416, 100441, 100450, 100454, 100461, 100463, 100465, 100466, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100512, 100517 & 100518.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • Descripción del producto
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. || Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • 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