Class IIDeviceOngoing

Philips Ultrasound, LLC

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Reason for recall

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.

Details

Recall number: Z-3249-2026
Event ID: 99706
Recall initiated: Aug 7, 2026
Classified: Sep 18, 2026
Reported: Sep 30, 2026
Quantity: 219 units
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.
Initiated by: Voluntary: Firm initiated
Firm location: Bothell, WA, United States
Lot / code info: All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125