Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujifilm Medical Systems U.S.A., Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74372
  • Event Risk Class
    Class 2
  • Event Number
    Z-2043-2016
  • Event Initiated Date
    2016-05-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147292
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • 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 .

Device

Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020
  • Model / Serial
    Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: CA, FL, KS, NE, NY, and PA.
  • Product 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.
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • Manufacturer Address
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA