Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report: 2/10/2021
Class II
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.
Recall Number: Z-0918-2021
REASON
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/MANUFACTURER
Fujifilm Medical Systems U.S.A., Inc. on 1/31/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
U.S. Nationwide