FDA-Device2026-09-30Class IIPROCESSING DEFECT
Philips EPIQ Elite ultrasound system recalled for doppler measurement software error
What this means
A software issue in Philips EPIQ Elite ultrasound systems (Model 795234, software version 14.0) causes doppler blood flow measurements to display at incorrect depths. This can lead to inaccurate velocity readings and potential misdiagnosis of vascular conditions. About 219 units are affected worldwide.
- Contact Philips technical support to determine if your system is affected by the software version
- Do not use affected units for doppler blood flow measurements until a fix is provided
- Review any recent doppler measurements taken with this system with your quality team
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
219 units
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3249-2026Want us to check the next one for you?
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