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Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Recalled October 27, 2021 · FDA recall Z-0123-2022 · Philips Ultrasound
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. · FDA Class II
Units
107
Sold at
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
Description
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.
Product
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Manufacturer(s)
Philips Ultrasound Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →