Philips Ultrasound, LLC recalls Philips EPIQ Elite Diagnostic Ultrasound System
- Recalling company
- Philips Ultrasound, LLC
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 7, 2026
- Reported
- Sep 30, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 219 units
- Lot / codes
- All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
- Company location
- Bothell, WA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3249-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3249-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.