FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a ...
FDA Recall #Z-0918-2021 — Class II — December 11, 2020
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.
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.
Recalling Firm
Fujifilm Medical Systems U.S.A., Inc. — Lexington, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
US Nationwide distribution in the state of MD.
Code Information
Versions 7.0.0 and 7.0.1
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated