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