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
- Recall Number
- Z-2111-2021
- Event Number
- 88101
- Firm
- Caption Health
- FEI Number
- 3016665037
- Product Code
- QIH
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 19, 2021
- Terminated
- January 31, 2023
- Address
- 2000 Sierra Point Pkwy, Fl 8, Brisbane, CA, 94005-1845
Description
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)
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.
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
US : AZ, DE, NY, IL, CT OUS: None
15 systems