FDA recall Z-2111-2021

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)

Reason for recall

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.

Distribution

US : AZ, DE, NY, IL, CT OUS: None

Key facts

Status

Terminated

Initiation date

2021-05-19

Report date

2021-07-28

Termination date

2023-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brisbane, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2111-2021