Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Published September 30, 2026 · Recall initiated: August 7, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Philips Ultrasound, LLC
- Distributor
- 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.
- Lot
- All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recalled?
Yes. FDA published recall Z-3249-2026 on September 30, 2026. Reported hazard: 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 should I do if I have this product?
Voluntary: Firm initiated
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