Jul

2021

Recall – Ultrasound software adds unintentional video frames

Company: Caption Health
Date of Enforcement Report: 7/28/2021
Class II

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)

Recall Number: Z-2111-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Caption Health on 5/19/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

15 systems

DISTRIBUTION

U.S. Nationwide

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Recall – Ultrasound software adds unintentional video frames

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