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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Caption Health
Lot Codes / Batch Numbers
All product containing software version 1.2.0
Products Sold
All product containing software version 1.2.0
Caption Health is recalling Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application So due to The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect autom. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CT, DE, IL, NY
Page updated: Jan 10, 2026