Events

Retiro De Equipo (Recall) de Device Recall Brilliance CT 6slice,16slice, 40channel, 64channel,Big Bore Oncology & Brilliance iCT and 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
    Recall
  • ID del evento
    62498
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2035-2012
  • Fecha de inicio del evento
    2012-07-02
  • Fecha de publicación del evento
    2012-07-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110763
  • 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 was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their brilliant ct scanner have been found to be defective and the bolt heads may break off.
  • Acción
    Philips sent a Urgent Medical Device Correction letter dated June 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will visit each site to inspect and correct the issue, and Philips will be tracking the progressof the correction. For further information, Customers were asked to contact their local Philips representative or Philips Healthcare Office. North American and Canadian consignees should contact the Philips Customer Care Solutions Center at 1-800-722-9377

Device

Device Recall Brilliance CT 6slice,16slice, 40channel, 64channel,Big Bore Oncology & Brilliance ...
  • Modelo / Serial
    Brilliance 64, M/N #728231, Serial #s,  10140, 10141,10142, 10143, 10144, 10145, 10146, 10147, 10148, 10149, 10150, 10151, 10152,10153, 10154, 10155, 10156, 10157, 10158, 10159, 10160, 10161, 10162, 10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10189, 10190, 10191, 10192, 10193, 10194, 10195, 10196, 10197, 10198, 10200, 10203, 10204, 10206, 10207, 10208, 10209, 10210, 10211, 10213, 10216, 10218, 10221, 10222, 10223, 10224, 10225, 10226, 10229, 10230, 10232, 10233, 10234, 10237, 10238, 10239, 10241, 10242, 10243, 10244, 10245, 10247, 10248, 10249, 10250, 10252, 10255, 10256, 10257, 10258, 10259, 10260, 10262, 10263, 10264, 10266, 10267, 10268, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300 Brilliance 40, M/N #728235, Serial #s  9258, 9259, 9260, 9261, 9262, 9263, 9264, 9265, 9266, 9267, 9268 Brilliance Big Bore, M/N #728243 Serial #s 7445, 7446, 7447, 7448, 7449, 7450, 7451, 7454, 7455, 7456, 7457, 7459, 7462, 7463, 7464, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7487, 7488, 7489, 7490, 7491, 7492, 7493, 7494, 7495, 7496, 7497, 7498, 7499, 7500, 7501, 7502, 7503, 7504, 7505, 7506, 7507, 7508, 7509, 7511, 7512, 7513  Brilliance Big Bore, M/N #728244 Serial #s 7452, 7453, 7458, 7486, 7510, 7514 Brilliance 16, M/N #728246 Serial #s 5990, 5991, 5992, 5993, 5994, 5995, 5996, 5997, 5998, 5999, 6000, 6001, 6002, 6003, 6004, 6005, 6006, 6007, 6008, 6009, 6010, 6011, 6012, 6013, 6014, 6015, 6016, 6017, 6018, 6020, 6021, 6022, 6023, 6024, 6025, 6026, 6027, 6028, 6029, 6030, 6031, 6032, 6033, 6034, 6035, 6036, 6037, 6038, 6039, 6040, 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6055, 6056, 6058, 6059, 6060, 6061, 6062, 6063, 6064, 6065, 6066, 6067, 6068, 6069, 6070, 6071, 6072, 6073, 6074, 6075, 6076, 6077, 6078, 6079, 6080, 6081, 6082, 6083, 6084, 6085, 6086, 6087, 6088, 6089, 6090, 6091, 6092, 6093, 6094, 6095, 6096, 6097, 6098, 6099, 6100, 6101, 6102, 6104, 6105, 6106, 6107, 6108, 6109, 6110, 6111, 6112, 6113, 6114, 6115, 6117, 6118, 6119, 6120, 6121, 6122, 6123, 6124, 6125, 6126, 6127, 6128, 6129, 6130, 6131, 6132, 6133, 6134, 6135, 6136, 6137, 6138, 6139, 6140, 6141, 6142, 6143, 6144, 6145, 6146, 6147, 6148, 6149, 6150, 6151, 6152, 6153, 6154, 6155, 6156, 6157, 6158, 6159, 6160, 6163, 6165, 6166, 6167, 6168, 6169, 6170, 6171, 6172, 6173, 6174, 6175, 6176  Brilliance 6, M/N #728256 Serial # 3669, 3670, 3671, 3672, 3673, 3674, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3682, 3683, 3684, 3685, 3686, 3687, 3688, 3689, 3690, 3691, 3692, 3693, 3694, 3695, 3696, 3697, 3698, 3699, 3700, 3701, 3702, 3703, 3704, 3705, 3706, 3707, 3708, 3709 Brilliance iCT, M/N #728306 Serial #s 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100155, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170  Brilliance iCT SP, M/N #728311 Serial #s 200006, 200007, 200008, 200009, 200010, 200011, 200012, 200013, 200015, 200016, 200017, 200018, 200019, 200020, 200021, 200022, 200023, 200024, 200025, 200026, 200027, 200028, 200029, 200030, 200031, 200032, 200033, 200034, 200035, 200036, 200037, 200038
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, MJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, VT, and WI. and the countries of Canada, Argentina, Australia, Austria, Azerbaijan, Brazil, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Iceland, India, Indonesia, Iraq, Italy, Jordan, Kazakhstan, Kazakhstan, Libyan Arab Jamahiriya, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Palestine, Peru, Philipines, Poland, Portugal, Russia, Russia Fed, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
  • Descripción del producto
    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. || The devices are Computed Tomography 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
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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