Events

Retiro De Equipo (Recall) de Device Recall Brilliance Workspace Portal

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
    61250
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1219-2012
  • Fecha de inicio del evento
    2012-02-23
  • Fecha de publicación del evento
    2012-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107661
  • 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, tomography, computed, emission - Product Code KPS
  • Causa
    Incorrect standardized uptake value ("suv") values are displayed in two instances: 1. after loading pet data (with a slope value different than 1) into the quick review (qr) application from a remote device; and 2. during the loading the above mentioned type of pet data into the ct viewer application from a remote device.
  • Acción
    The Philips Healthcare, sent an "URGENT-Medical Device Correction" Field Safety Notice dated February 08, 2012 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of their staff and to retain a copy with the equipment Instruction for Use. The letter notifies the customers that a Field Service Engineer will be contacting them to schedule a visit to implement the corrective action by installing the software update version 2.6.1. If you need further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Device

Device Recall Brilliance Workspace Portal
  • Modelo / Serial
    Model #: 728269; Serial #s: 79901, 79902, 79903, 79904, 79905, 79906, 79907, 79910, 79911, 79912, 79913, 79914, 79916, 79917, 79918, 79920, 79921, 79922, 79923, 79924, 79925, 79926, 79927, 79928, 79929, 79930, 79931, 79932, 79934, 79935, 79936, 79937, 79939, 79940, 79942, 79943, 79944, 79945, 80002, 80005, 80006, 80007, 80009, 80010, 80011, 80025, 80026, 80027, 80031, 80032, 80037, 80039, 80040, 80041, 80042, 80047, 80053, 80054, 80056, 80058, 80059, 80060, 80061, 80062, 80063, 80065, 80066, 80067, 80068, 80069, 80070, 80071, 80072, 80073, 80075, 80076, 80077, 80078, 80079, 80080, 80081, 80082, 80084, 80085, 80086, 80087, 80088, 80091, 80093, 80094, 80095, 80096, 80097, 80098, 80109, 80110, 80111, 80112, 80113, 80114, 80115, 80116, 80117, 80119, 80121, 80123, 80128, 80129, 80130, 80133, 80134, 80137, 80139, 80140, 80141, 80143, 80145, 80146, 80147, 80148, 80149, 80150, 80151, 80152, 80153, 80154, 80155, 80156, 80157, 80158, 80160, 80161, 80162, 80163, 80164, 80165, 80166, 80167, 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80331, 80332, 80333, 80334, 80335, 80336, 80337, 80339, 80340, 80341, 80344, 80345, 80346, 80347, 80348, 80349, 80350, 80353, 80354, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80377, 80378, 80379, 80380, 80381, 80382, 80383, 80384, 80385, 80386, 80387, 80389, 80390, 80391, 80392, 80393, 80394, 80395, 80396, 80397, 80398, 80399, 80401, 80402, 80406, 80409, 80410, 80416, 80417, 80418, 80419, 80420, 80421, 80422, 80423, 80424, 80425, 80427, 80428, 80429, 80430, 80431, 80432, 80433, 80435, 80436, 80437, 80438, 80439, 80440, 80442, 80443, 80444, 80445, 80446, 80447, 80448, 80449, 80450, 80451, 80453, 80454, 80455, 80456, 80458, 80459, 80460, 80461, 80462, 80463, 80464, 80466, 80467, 80470, 80471, 80472, 80473, 80474, 80475, 80476, 80477, 80479, 80480, 80481, 80482, 80483, 80484, 80485, 80486, 80487, 80488, 80489, 80491, 80492, 80493, 80494, 80495, 80496, 80497, 80502, 80503, 80504, 80505, 80506, 80507, 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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distributions: USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, VA, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WI, and WV; and countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech, Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Poland, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Venezuela.
  • Descripción del producto
    The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. || The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is 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 Road, Cleveland OH 44143-2131
  • Source
    USFDA