Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synapse Cardiology PACS V7.3.0 Recalled by FUJIFILM Healthcare Americas Corporation Due to The LV Mass (2D Bullet) equation may be...
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 Healthcare Americas Corporation directly.
Affected Products
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Quantity: 13
Why Was This Recalled?
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report