Events

Retiro De Equipo (Recall) de Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY)

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 Fujifilm Medical Systems U.S.A., 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
    74525
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2690-2016
  • Fecha de inicio del evento
    2016-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147840
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Causa
    If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
  • Acción
    The firm, Fujifilm, sent a "FIELD SAFETY NOTICE" letter dated June 9, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to read and follow the instructions in the letter; call your local service representative, in case an error occurs, and complete and return the Customer Feedback Form via fax (203)-251-7862. Both affected systems will be corrected via on-site visits by FMSU Customer Service Engineers. If you have any questions about this matter, please contact the Product Manager, Women's Health directly at (303)-888-4549 or call your local FUJIFILM office.

Device

Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner ...
  • Modelo / Serial
    26330437 and 17230408
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to: NC and HI.
  • Descripción del producto
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) || The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • Dirección del fabricante
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Empresa matriz del fabricante (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA