Recall Z-2111-2021 ยท QIH Automated Radiological Image Processing Software
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)
| Date | May 19, 2021 |
| Status | Terminated |
| 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 |
| Quantity | 15 systems |
| Distribution | US : AZ, DE, NY, IL, CT OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200621 | Caption Interpretation Automated Ejection Fraction Software Caption Health, Jul 22, 2020 |