Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EPIQ CVxi Diagnostic Ultrasound Systems Recalled by Philips Ultrasound Inc Due to Ultrasound system software issue can cause an EchoNavigator...

Date: September 21, 2021
Company: Philips Ultrasound Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound Inc directly.

Affected Products

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Quantity: 107

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 18 states: AZ, CA, CO, IL, IN, IA, KY, LA, MD, MI, NJ, NY, NC, OH, PA, TN, TX, WI

Affected (18 states)Not affected

About Philips Ultrasound Inc

Philips Ultrasound Inc has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report