FDA-Device2021-10-27Class II
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips Ultrasound Inc
Hazard
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.
Sold states
US: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, New Zealand
Affected count
107
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2022Don't want to check this manually?
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