BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2043-2016 · Initiated May 10, 2016

    Recall

    Recall Number
    Z-2043-2016
    Event Number
    74372
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 10, 2016
    Terminated
    February 20, 2019
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    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.

    Reason

    Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

    Action

    The firm, FujiFilm, sent an "MEDICAL DEVICE CORRECTION" letter dated May 10, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken.The customers were instructed to: Extend the Ad hoc deletion retention period or discontinue use of Ad Hoc Deletion, and complete and submit the attached Customer Response Form to Fujifilm via fax to (203)-251-7863. Affected systems will be corrected via on-site visits by FMSU Customer Service Engineers upgrading to Version 4.4.100. Questions or concerns, contact the FUJI FILM Customer Support Center at 1- 888-FUJIMED Option #1 .

    Distribution

    US Distribution to states of: CA, FL, KS, NE, NY, and PA.

    Quantity

    27 units