Company: Philips Ultrasound, LLC
Date of Enforcement Report: 9/18/2026
Class: II

PRODUCT

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Recall Number:

Z-3249-2026

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.

RECALLING FIRM/MANUFACTURER:

Philips Ultrasound, LLC

VOLUME:

484 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.