Philips Ultrasound, LLC: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
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- Company / brand
- Philips Ultrasound, LLC
- Product
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-08-07
- 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
- Product quantity
- 219 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bothell
- State
- WA
- Country
- United States
- Event id
- 99706
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