Lower risk Medical device recall · FDA · Published September 21, 2021

Philips EPIQ CVxi Ultrasound Systems Recall: Software Error May Cause Treatment Delays

Philips recalls EPIQ CVxi ultrasound systems with software versions 6.0, 7.0, 7.0.3 due to potential treatment delays from EchoNavigator errors. Affected units may require system restarts during certain procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0123-2022Medical device Philips ›

Lower-risk 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.

Take action

Contact the company

Recalling firmPhilips Ultrasound Inc22100 Bothell Everett Hwy · Bothell, WA 98021-8431

✎ GovInfoNow plain-language explainer

Philips is recalling EPIQ CVxi ultrasound systems with software versions 6.0, 7.0, and 7.0.3. The software issue can cause the system to become unresponsive during ultrasound-guided procedures, potentially delaying or causing unnecessary treatments. Read more at govinfonow.com/recall/61788-philips-epiq-cvxi-ultrasound-systems-recall-software-error-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/61788-philips-epiq-cvxi-ultrasound-systems-recall-software-error-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0123-2022

Cite this page

“Philips EPIQ CVxi Ultrasound Systems Recall: Software Error May Cause Treatment Delays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61788-philips-epiq-cvxi-ultrasound-systems-recall-software-error-may-cause. Based on FDA recall #Z-0123-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2022%22&limit=1).

Philips Ultrasound, Inc., on behalf of itself and the FDA, recalled EPIQ CVxi Diagnostic Ultrasound Systems due to a software issue that can cause an unresponsive system. The recall was announced on September 21, 2021.

How to tell if you have it

Brand: Philips
Product: EPIQ CVxi Diagnostic Ultrasound Systems
Product Code: 795232
Software Versions: 6.0, 7.0, 7.0.3
Units affected: 107

The hazard

A software issue can cause an EchoNavigator error notification leading to an unresponsive system that requires a restart. This may result in therapy or treatment delays and/or unnecessary therapy or treatment, particularly during ultrasound-guided TEE with EchoNavigator if secondary screen capture is enabled.

Context

GovInfoNow's records show Philips Ultrasound, Inc has had 14 other recalls on record since April 29, 2019. Recent recalls include the Philips S5-1 Ultrasound Transducer Recall on September 5, 2025, and the Philips S7-2t Transducer Probe Recall on July 3, 2025. Other recent recalls of similar products include the Philips EPIQ Elite Ultrasound System Recall (August 7, 2026), the Philips PIC iX Essentials Software Freezes recall (July 31, 2026), and the Philips Achieva 3.0T MRI Recalled (August 21, 2026).

How to tell if you have this one

Check if your Philips EPIQ CVxi ultrasound system has software versions 6.0, 7.0, or 7.0.3. The product code is 795232.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by checking the device settings or documentation.

Where it went and when

Where it was distributed

Distributed in 18 states, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Sep 21, 2021Firm started the recall
Oct 15, 2021FDA classified it Class II
Oct 27, 2021Published in FDA’s Enforcement Report
Apr 12, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61788-philips-epiq-cvxi-ultrasound-systems-recall-software-error-may-cause">Philips EPIQ CVxi Ultrasound Systems Recall: Software Error May Cause Treatment Delays (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0123-2022 (September 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0123-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.