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)
FDA Recall Z-2111-2021 · Posted None
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Recalling FirmCaption Health
Recall StatusTerminated
Product CodeQIH
Date Initiated2021-05-19
Date Terminated2023-01-31
Product Quantity15 systems
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.
Firm 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
Root Cause
Software design
Distribution Pattern
US : AZ, DE, NY, IL, CT OUS: None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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