Events

Retiro De Equipo (Recall) de Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanner

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
    65139
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1646-2013
  • Fecha de inicio del evento
    2013-04-15
  • Fecha de publicación del evento
    2013-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118867
  • 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
    Philips healthcare received reports from the field that certain brilliance ct 64, ingenuity core, and ingenuity core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
  • Acción
    Philips Healthcare sent an Urgent Medical device Correction letter dated April 15, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to resolve the issue and a Philips Field Service Engineer will contact each site to schedule the software installation. For questions contact your local Philips representative or local Philips Healthcare office.

Device

Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanner
  • Modelo / Serial
    The following system code numbers and associated serial numbers are affected by this recall:  System Code #728231, Serial #: 4001, 4003, 4016, 4020, 9009, 9029, 9030, 9033, 9034, 9037, 9038, 9040, 9041, 9043, 9044, 9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9063, 9064, 9065, 9066, 9067, 9068, 9069, 9070, 9071, 9072, 9073, 9074, 9075, 9077, 9080, 9081, 9083, 9086, 9087, 9088, 9089, 9092, 9093, 9094, 9096, 9098, 9099, 9104, 9105, 9106, 9107, 9108, 9112, 9118, 9120, 9126, 9127, 9131, 9135, 9137, 9138, 9140, 9142, 9143, 9148, 9151, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9172, 9173, 9175, 9177, 9180, 9187, 9190, 9195, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9213, 9214, 9215, 9216, 9217, 9218, 9235, 9243, 9259, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 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310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310023, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310065, 310066, 310067, 310068, 310069, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 333001, 333007 System Code #728323, Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047.320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
  • Descripción del producto
    Computed Tomography X-ray systems || Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • 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