# FDA recall Z-0123-2022

> **Philips Ultrasound Inc** · Class II · device recall initiated 2021-09-21.

## 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

- **Recall number:** Z-0123-2022
- **Recalling firm:** Philips Ultrasound Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0123-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0123-2022. Source: US FDA. Licensed CC0.

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