Brisbane, CA, United States
Caption Health recalls
1 recall recorded since 2018, most recently on 19 May 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 19 May 2021
- Terminated
- 31 January 2023
- 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.
- Distribution
- US : AZ, DE, NY, IL, CT OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2111-2021
- 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)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.