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Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application o
Recalled February 3, 2021 · FDA recall Z-0918-2021 · Fujifilm Medical Systems U.S.A
Hazard
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. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of MD.
Description
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.
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.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →