Version: 1 — Class II medical device recall Z-2111-2021
Terminated recall by Caption Health, reported 2021-07-28, distributed in AZ, CT, DE, IL, NY. The firm is aware of a issue with ultrasound software that results in unintended video frames being included.
| Recall number | Z-2111-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caption Health, Brisbane, CA, United States |
| Recall initiated | 2021-05-19 |
| Classified | 2021-07-22 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2023-01-31 |
| Distributed | AZ, CT, DE, IL, NY |
| Quantity | 15 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860003586303 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2111-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.