Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report 6/29/2016
Class lI:

PRODUCT

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 Number Z-2043-2016

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

RECALLING FIRM/MANUFACTURER
Fujifilm Medical Systems U.S.A., Inc. Stamford, CT on 5/10/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
27 units

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

___________________________________