medical Class II Updated 2021-10-27

Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 79523

Recalled Product

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Hazard / Issue

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.

Issued by

FDA

Affected States: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA
Lot/Code Info: Software Versions: 6.0, 7.0, 7.0.3
View official government recall

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