Z-0123-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- September 21, 2021
- Termination Date
- April 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107
Product Description
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 Pattern
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
Code Information
Software Versions: 6.0, 7.0, 7.0.3