Fujifilm Medical Systems U.S.A., Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Fujifilm Medical Systems U.S.A., Inc.
Lot Codes / Batch Numbers
Versions 7.0.0 and 7.0.1
Products Sold
Versions 7.0.0 and 7.0.1
Fujifilm Medical Systems U.S.A., Inc. is recalling FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web due to The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the st. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 12/11/2020 Fujifilm sent consignee notifications via FedEx Priority Overnight stating that there are issues with Synapse PACS Software Version 7.0.000 and 7.0.100. Fujifilm provided a work around until a hotfix is scheduled and completed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026