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Caption Health recalls Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873)
Recalled July 28, 2021 · FDA recall Z-2111-2021 · Caption Health
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. · FDA Class II
Units
15 systems
Sold at
US : AZ, DE, NY, IL, CT OUS: None
Description
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.
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)
Manufacturer(s)
Caption Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →