Philips Ultrasound Inc: Medical Device Recall in 2021 - (Recall #: Z-0123-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Product Classification:

Class II

Date Initiated: September 21, 2021

Date Posted: October 27, 2021

Recall Number: Z-0123-2022

Event ID: 88728

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.

Status: Terminated

Product Quantity: 107

Code Information:

Software Versions: 6.0, 7.0, 7.0.3

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

Voluntary or Mandated:

Voluntary: Firm initiated