Recall – PACS software fails to update measurements under certain conditions

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

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