Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to Measurement values in the EMR may not accurately...
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
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Quantity: 30 units
Why Was This Recalled?
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Where Was This Sold?
This product was distributed to 16 states: CA, FL, IL, IN, MD, MI, MN, MO, NY, NC, OH, OR, PA, TX, VA, WI
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