Reported Jul 28, 2021 · Terminated
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN:…
Caption Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Caption Health · 2000 Sierra Point Pkwy Fl 8 · Brisbane, CA · 94005-1845
Is this the product you have?
- Version1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging
- System Application Software (GMDN40873)
- UDI(01)00860003586303(10)1.2.0)
- Lot codes and dates
- All product containing software version 1.2.0
- Amount recalled
- 15 systems
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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