Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall (Philips Ultrasound, LLC)
Medical deviceClass IIOngoing
Summary: Philips Ultrasound, LLC is recalling Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234. Reason: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
What is being recalled
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Why
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS, MD, MN, NJ, NY, OH, PA, SC, TN, TX, VA, WA, WI 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. (states named: Alabama, California, Connecticut, Florida, Georgia, Kansas, Maryland, Minnesota, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin)
How to tell if yours is affected
All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3249-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 7, 2026 |
| Reported | September 30, 2026 |
| Company | Philips Ultrasound, LLC |
| Company location | Bothell, WA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 219 units |
More recalls from Philips Ultrasound, LLC · all medical device recalls · recalls from August 2026