Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Version: 1.2.0 (1.2.0+85ela410) Caption Health Recalled by Caption Health Due to The firm is aware of a issue with...
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 Caption Health directly.
Affected Products
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
Quantity: 15 systems
Why Was This Recalled?
The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.
Where Was This Sold?
This product was distributed to 5 states: AZ, CT, DE, IL, NY
About Caption Health
Caption Health has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report