FDA recall Z-0123-2022

Philips Ultrasound Inc · Class II · device

Product

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2021-09-21
Report date: 2021-10-27
Termination date: 2024-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2022