Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2016 - (Recall #: Z-2043-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 10, 2016

Date Posted: June 29, 2016

Recall Number: Z-2043-2016

Event ID: 74372

Reason for Recall:

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

Status: Terminated

Product Quantity: 27 units

Code Information:

Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated