FDA Medical Device Recalls (openFDA)
Caption Health: 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)
- Recall number
- Z-2111-2021
- Recalling firm
- Caption Health
- 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)
- Status
- Terminated
- Initiated
- 2021-05-19
- Posted
- not on file
- Terminated
- 2023-01-31
- 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.
- Root cause
- Software design
- Action
- On May 19, 2021 Caption health, Inc. contacted consignees via telephone to inform them about their recall. On May 20, 2021, the firm sent follow-up communication via via email. In addition to informing consignees about the recall, the firm also asked customers to take the following actions: 1. Until your system is updated, we recommend that all EF calculations are reviewed carefully using clinical expertise, to verify the accuracy of the results. 2. If you have any questions or concerns, please contact Caption health support line at 1-855-506-HELP between 7am-7pm ET. You can also email us at support@captionhealth.com at any time. We will follow-up with additional details relevant to your site by Monday May 24
- Quantity
- 15 systems
- Distribution
- US : AZ, DE, NY, IL, CT OUS: None
- Lot, serial or model codes
- All product containing software version 1.2.0
- 510(k) numbers
- ["K200621"]
- PMA numbers
- not on file
- Product code
- QIH
- Firm FEI
- 3016665037
- Firm city
- Brisbane
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28