Events

Retiro De Equipo (Recall) de Device Recall Artis zee/zeego, system xray, angiographic

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 Siemens Medical Solutions USA, 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
    73672
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1284-2016
  • Fecha de inicio del evento
    2016-02-18
  • Fecha de publicación del evento
    2016-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144719
  • 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, angiographic - Product Code IZI
  • Causa
    Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. loss of coolant can result in a cooling system failure and subsequent system failure. this leak can occur sporadically in affected systems.
  • Acción
    Siemens sent an Important Customer Safety Notice to customers on February 18, 2016 informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings with metal couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an earlier appointment at 1-800-888-7436.

Device

Device Recall Artis zee/zeego, system xray, angiographic
  • Modelo / Serial
    Serial Numbers:  Artis Q Ceiling   109033, 109135, 109141, 109123, 109080, 109074, 109119, 109016, 109118, 109155, 109067, 109066, 109068, 109134, 109133, 109084, 109011, 109096, 109159, 109130, 109143, 109102, 109015, 109144, 109009, 109057, 109108, 109103, 109038, 109040, 109034, 109129, 109137, 109029, 109136, 109064, 109132, 109058, 109145, 109050, 109076, 109007, 109072, 109075, 109071, 109091, 109090, 109041, 109039, 109060, 109146, 109088, 109092, 109032, 109021, 109048, 109020, 109036, 109043, 109161, 109101, 109105, 109104, 109107, 109047, 109031, 109028, 109027, 109120, 109010, 109093, 109157, 109156, 109069, 109158, 109044
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.
  • Descripción del producto
    AXIOM Artis zee/zeego, system, x-ray, angiographic || Product Usage: || AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA