Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2016 - (Recall #: Z-0073-2017)

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 versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities

Product Classification:

Class II

Date Initiated: September 15, 2016

Date Posted: October 19, 2016

Recall Number: Z-0073-2017

Event ID: 75192

Reason for Recall:

Image data for a patients image may not be correct

Status: Terminated

Product Quantity: 251 units

Code Information:

Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated