FDA Device recall Z-2111-2021
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003…
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003… by Caption Health, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2111-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-19 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Caption Health |
| Distribution | AZ, CT, DE, IL, NY |
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
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.
Identifiers
| code_info | All product containing software version 1.2.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2111-2021%22
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