Events

Retiro De Equipo (Recall) de FullField Digital Mammography Xray System

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
    79078
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0659-2018
  • Fecha de inicio del evento
    2017-08-04
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161290
  • 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
    Fujifilm medical systems u.S.A., inc. (fmsu) identified a potential failure with our mammography system. the acquisition workstations, fdr¿1000aws, fdr-2000aws, fdr-3000aws, and cr¿ir363aws assign a unique id number to every image study but very rarely, with the acquisition workstation software versions, vs.O, vs.1, vs.2 , v6.0, v6.1, and v7.0, the system may assign the same id number to a new set of images that was already assigned to the previous set of images due to the error in id number generation logic. if an image with this error (with duplicate id number) is transmitted to pacs, it may overwrite the image already stored on pacs.
  • Acción
    The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures.. If you have any questions about this matter, call Recall contact (203) 276-3445 or email: dharaben.desai@fujifilm.com.

Device

FullField Digital Mammography Xray System
  • Modelo / Serial
    1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Aspire HD (for FDR-1000AWS) || The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), 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