medical Class II Updated 2021-02-03

Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - P

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Versions 7.0.0 and 7.0.1
View official government recall

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