Events

Retiro De Equipo (Recall) de Device Recall Vertical Brake Hubs of the Computed Tomography XRay Systems

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
    57690
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1669-2011
  • Fecha de inicio del evento
    2010-12-10
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97889
  • 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
    Philips medical systems has decided to recall the patient support vertical brake hub in all its brilliance systems due to the collapse in the vertical direction. the short key connecting the vertical brake hub to the motor shaft can disengage due to the lack of thread locker on set screws.
  • Acción
    Philips Medical Systems (Cleveland) Inc sent Field Safety Notice to all affected customers on December 10, 2010. The Safety Notices identified the product, the problem, and the action to be taken by the customer. Customers were instructed to monitor their units and if the vertical brake hub malfunctioned to immediately contact the recalling firm. The letter also stated that a Field Service Engineer would visit to perform a brake hub rework on the units. For further information or support customers were to contact their 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 prompt(s). For questions regarding this recall call 440-483-7672.

Device

Device Recall Vertical Brake Hubs of the Computed Tomography XRay Systems
  • Modelo / Serial
    Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including 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, MT,NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Afghanistan; Algeria; Angola; Argentina; Australia; Austria; Azerbaijan; Bahamas; Bahrain; Bangladesh; Belgium; Bolivia; Bosnia & Herzegovina; Brazil; Brunei Darussalam; Bulgaria; Cambodia; Canada; Chile; China; Columbia; Costa Rica; Cote d'Ivoire; Croatia; Cyprus; Czech Republic; Denmark; Dominican Republic; Ecuador; Egypt; El Salvador; England; Equatorial Guinea; Finland; France; French Polynesia; Germany; Greece; Hong Kong; Hungary; Iceland; India; Indonesia; Iran; Iraq; Ireland; Israel; Italy; Jamaica; Japan; Jordan; Kazakhstan; Kenya; Kuwait; Latvia; Lebanon; Libyan Arab Jamahiriya; Lithuania; Luxembourg; Madagascar; Malaysia; Malta; Martinique; Mexico; Monaco; Mongolia; Morocco; Mozambique; Namibia; Nepal; Netherlands; Netherlands; Antilles; New Zealand; Nicaragua; Nigeria; Norway; Oman; Pakistan; Panama; Paraguay; Peru; Philippines; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia & Montenegro; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Switzerland; Syrian Arab Republic; Taiwan; Tanzania; Thailand; Tunisia; Turkey; Ukraine; Unidentified KM; United Arab Emirates; United Kingdom; Uzbekistan; Venezuela; Viet am & Yemen.
  • Descripción del producto
    Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034. || The Brilliance Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices 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