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Caption Health Recalls

1 recall on record · July 28, 2021 to July 28, 2021 · Medical Devices

July 28, 2021Medical DevicesFDA

Caption Health recalls Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873)

Hazard: 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.

Caption Health Recalls | RecallWatchUSA