Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020

  • Modelo / Serial
    Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, FL, KS, NE, NY, and PA.
  • Descripción del producto
    Fujifilm Synapse PACS software version 4.4.000, || Fujifilm Synapse PACS software version 4.4.001, || Fujifilm Synapse PACS software version 4.4.004, || Fujifilm Synapse PACS software version 4.4.010 and || Fujifilm Synapse PACS software version 4.4.020 || FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an || off-the-shelf PC networked with Fuji Synapse PACS.
  • Manufacturer
  • 1 Event

Fabricante

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