Class II

Medical Device Recall: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Philips Ultrasound, LLC · August 7, 2026

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.

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.

States Affected

NATIONWIDE

Quantity Affected

219 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3249-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips Ultrasound, LLC Medical Device Recall: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 | SafeCheck