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

Recall date

May 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2111-2021

FDA classification

Class II

Brand / firm

Caption Health

Sold / distributed

US : AZ, DE, NY, IL, CT OUS: None

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)