Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2021 - (Recall #: Z-0918-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

Product Classification:

Class II

Date Initiated: December 11, 2020

Date Posted: February 3, 2021

Recall Number: Z-0918-2021

Event ID: 87083

Reason for Recall:

The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Versions 7.0.0 and 7.0.1

Distribution Pattern:

US Nationwide distribution in the state of MD.

Voluntary or Mandated:

Voluntary: Firm initiated