Device 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)
Z-2111-2021
Product summary
- Firm
- Caption Health
- Event
- Event 88101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 systems
- Official record key
device-enforcement:Z-2111-2021
Official wording
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.
Code information: All product containing software version 1.2.0
Distribution pattern: US : AZ, DE, NY, IL, CT OUS: None
Derived failure modes
-
Device software or design
issue with ultrasound software