Reported Oct 27, 2021 · Terminated
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips Ultrasound Inc.
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: Philips Ultrasound Inc · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- EPIQ CVxi Diagnostic Ultrasound Systems
- Product Code795232
- Lot codes and dates
- Software Versions
6.07.07.0.3
- Software Versions
- Amount recalled
- 107
Where it was sold
Why it was recalled
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.
This product could cause temporary or reversible health problems — stop using it.
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