Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to The software does not update measurements and calculations...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical Systems U.S.A., Inc. directly.
Affected Products
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.
Quantity: 1 unit
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report