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)
Reported: July 28, 2021 Initiated: May 19, 2021 #Z-2111-2021
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.
Details
- Recalling Firm
- Caption Health
- Units Affected
- 15 systems
- Distribution
- US : AZ, DE, NY, IL, CT OUS: None
- Location
- Brisbane, CA
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Caption Health. Units affected: 15 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2111-2021.
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