- Recalling firm
- Philips Ultrasound, LLC
- 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.
- Affected products (lot / model / serial)
- All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
- Units affected
- 219 units
- Distribution pattern
- 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.
- Firm location
- Bothell, WA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3249-2026
- Recall initiated
- August 7, 2026
- FDA classification date
- September 18, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99706
- Last updated on HTM Vibe
- October 6, 2026
