FDA recall Z-0918-2021

Fujifilm Medical Systems U.S.A., Inc. · Class II · device

Product

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.

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.

Distribution

US Nationwide distribution in the state of MD.

Key facts

Status: Terminated
Initiation date: 2020-12-11
Report date: 2021-02-03
Termination date: 2021-11-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2021