medical Class II Updated 2021-07-28

Caption Health recalls Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI,

Recalled Product

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)

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, DE, NY, IL, CT
Lot/Code Info: All product containing software version 1.2.0
View official government recall

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