Device recall
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- Recall number
- Z-3249-2026
- Event id
- 99706
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Philips Ultrasound, LLC
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Aug 7, 2026
- Center classification date
- Sep 18, 2026
- Product code
- IYN
- Device type
- System, Imaging, Pulsed Doppler, Ultrasonic
- 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.
- Root cause
- Software Design Change
- Quantity
- 219 units
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Bothell, WA, United States