Philips EPIQ Elite Diagnostic Ultrasound System
The Philips EPIQ Elite ultrasound system has a software issue that can cause inaccurate blood flow measurements and misdiagnosis.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Philips Ultrasound, LLC is recalling the Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 due to a software issue that causes the doppler sample to be displayed shallower than its actual measurement location, potentially leading to inaccurate blood flow velocity measurements and misdiagnosis. The recall involves 484 units and began on August 7, 2026, with the FDA adding it to the Enforcement Report on September 18, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
Philips EPIQ Elite Diagnostic Ultrasound System
- Model
- 795234
- UDI-DI
- 00884838102514
- 00884838107540
- 00884838114159
- 00884838124912
- 00884838128125
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Alabama, California, Connecticut, Florida, Georgia, Kansas, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and the countries of Austria, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lithuania, Netherlands, Norway, Philippines, Poland, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan , United Kingdom, Vietnam.
- Event ID
- 99706
- Recall No.
- Z-3249-2026
- Company
- Philips Ultrasound, LLCBothell, Washington
- Hazard
- Software defect
- Quantity recalled
- 484 units
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
