FDADecember 11, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
fujifilm medical systems ufujifilmfujifilm medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
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