Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234: recall status
Notice names this product. Philips Ultrasound’s Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 is named in FDA Class II recall Z-3249-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: 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. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Company / brand
Philips Ultrasound
Lot / serial / date codes
All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
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.
Agency product description and boundaries
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measure…