Recall Z-2111-2021— Caption Health
Class II · Terminated
Class II FDA medical device recall by Caption Health, initiated 2021-05-19, terminated 2023-01-31. It names one FDA 510(k) clearance: K200621. 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). 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..
- Recalling firm
- Caption Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-19
- Terminated
- 2023-01-31
- Firm location
- Brisbane, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.