Events

Retiro De Equipo (Recall) de Device Recall TSX301A: AQUILION ONE

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 Toshiba American Medical Systems 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
    56407
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1665-2011
  • Fecha de inicio del evento
    2010-07-22
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93524
  • 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
    Toshiba america medical systems (tams) has found that communication may be cut off in the aquilion one/ premium systems, owing to the failure of a part used in the console.
  • Acción
    The firm, Toshiba America Medical Systems (TAMS), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 22, 2010, to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that a new relay will be installed to prevent the occurrence of the problem within the next 90 days and that their Toshiba Service Representative will contact them to install the part to their Aquilion ONE/Premium System. The customers were instructed to contact their Toshiba Service Representative, if the problem occurs before the corrective action has been taken; to share the information with all users and review radiologists as well as clinical engineering or Biomedical group at their facility, and to complete and return the attached CUSTOMER REPLY FORM via fax to 877-349-3054 or email to raffairs@tams.com. If you have any questions regarding this letter, please feel free to contact the Director, Regulator Affairs at (800) 421-1968 or your local Toshiba Representative at (800) 521-1968.

Device

Device Recall TSX301A: AQUILION ONE
  • Modelo / Serial
    Last 4 of serial number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2006, 2007, 2008, 2123, 2131, 2133, 2011, 2139, 2143, 2148, 2151, 2014, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2002, 2004, 2158, 2166, 2174
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: AL, AR, AZ, CA, CO, FL, GA, IA, KY, LA, MA, MD, MI, MN, MT, ND, NJ, NV, NY, OH, PA, PR, TX, VA, WI, and WY.
  • Descripción del producto
    TSX-301A: AQUILION ONE System || AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA