Lower risk Medical device recall · FDA · Published December 16, 2020

Philips EPIQ Ultrasound System Recall: Image Boost Causes Inaccurate Flow Visualization

Philips recalls EPIQ Elite, 5G, 5C, 7G, 7C, CVx & CVxi ultrasound systems due to Image Boost feature causing inaccurate blood flow visualization in certain transducers.

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

🇺🇸 FDA recall #Z-0944-2021Medical device Philips ›

Lower-risk recall

The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Philips is recalling several EPIQ ultrasound systems because the Image Boost feature can show inaccurate blood flow when used with specific transducers. This could lead to incorrect medical diagnoses if the ultrasound technician relies on the inaccurate flow visualization. Read more at govinfonow.com/recall/63648-philips-epiq-ultrasound-system-recall-image-boost-causes-inaccurate-flow.

Source Summary by GovInfoNow · govinfonow.com/recall/63648-philips-epiq-ultrasound-system-recall-image-boost-causes-inaccurate-flow · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0944-2021

Cite this page

“Philips EPIQ Ultrasound System Recall: Image Boost Causes Inaccurate Flow Visualization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63648-philips-epiq-ultrasound-system-recall-image-boost-causes-inaccurate-flow. Based on FDA recall #Z-0944-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0944-2021%22&limit=1).

Philips Ultrasound Inc recalled its EPIQ Diagnostic Ultrasound Systems on Dec. 16, 2020, according to the FDA. The devices may display inaccurate blood flow visualizations when Image Boost is enabled.

How to tell if you have it

Brand: Philips
Product: EPIQ Diagnostic Ultrasound System
Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi
Units affected: 607

The hazard

The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled, the color box shows flow visualization not accurately representing the fluid flow. Similarly, both CW and PW Doppler traces will not accurately represent the fluid flow.

Context

GovInfoNow's records show Philips Ultrasound, Inc has 14 other recalls on record since 2019-04-29. Other recent recalls of similar products include Philips OMNI II TEE Ultrasound Transducer Recall (2025-09-05), Philips S7-3t Transducer Probe Recall (2025-07-03) and Philips 3D9-3v Transducer Recall (2025-05-28). Other recent recalls of similar products include Philips EPIQ Elite Ultrasound System Recall (2026-08-07), PIE Medical Imaging 3mensio Workstation Software Recall (2026-05-07) and Philips Incisive CT Recall (2025-12-03).

How to tell if you have this one

Check if your Philips EPIQ ultrasound system has model numbers EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx, or EPIQ CVxi. The issue occurs when using the X8-2t TEE transducer with Image Boost enabled.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Settings
Ensure Image Boost is disabled when using the X8-2t TEE transducer to prevent inaccurate blood flow visualization.

Where it went and when

Where it was distributed

Distributed in 38 states, and outside the U.S.

FDA distribution: “US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Dec 16, 2020Firm started the recall
Feb 1, 2021FDA classified it Class II
Feb 10, 2021Published in FDA’s Enforcement Report
Mar 15, 2023FDA 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/63648-philips-epiq-ultrasound-system-recall-image-boost-causes-inaccurate-flow">Philips EPIQ Ultrasound System Recall: Image Boost Causes Inaccurate Flow Visualization (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-0944-2021 (December 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0944-2021 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.