Z-2111-2021Class II

Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software...

Name: Z-2111-2021 Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software...
Creator: Caption Health
Published: 2021-05-19
License: https://open.fda.gov/license/

Caption Health / initiated 2021-05-19 / Terminated / root cause: software

FDA source

Caption Health began a recall of 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) on 2021-05-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2111-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Posted: 2021-07-22
Terminated: 2023-01-31
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)
Product code: QIH Automated Radiological Image Processing Software
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.
Root cause tag: software
FDA 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 [email protected] at any time. We will follow-up with additional details relevant to your site by Monday May 24
Quantity in commerce: 15 systems
Distribution: US : AZ, DE, NY, IL, CT OUS: None
Product codes and lots: All product containing software version 1.2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2111-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-22

Product code QIH

K200621Class IICaption Interpretation Automated Ejection Fraction SoftwareCaption Health / cleared 2020-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)