FDA-Device2021-07-28Class II
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)
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.
Sold states
US : AZ, DE, NY, IL, CT OUS: None
Affected count
15 systems
Manufactured in
2000 Sierra Point Pkwy Fl 8, N/A, Brisbane, CA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2111-2021Don't want to check this manually?
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