Philips Ultrasound, LLC: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Is my product affected?

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

• UPC 00884838102514
• UPC 00884838107540
• UPC 00884838114159
• UPC 00884838124912
• UPC 00884838128125

Check against the official notice below — it lists the full affected range.

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.

Details from the source

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. Quantity: 219 units Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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