# FDA recall Z-2111-2021

> **Caption Health** · Class II · device recall initiated 2021-05-19.

## 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

- **Recall number:** Z-2111-2021
- **Recalling firm:** Caption Health
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2111-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2111-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*