Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to Software versions 6.0.4 to 6.2.1 using Advanced Reporting...
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 Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Quantity: 44 US and 4 OUS
Why Was This Recalled?
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
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