Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to FUJIFILM has become aware of the possibility that...
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
Synapse PACS Software Version 5.6.1 - 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
Why Was This Recalled?
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
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