Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, LLC · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- Lot codes and dates
- All Philips EPIQ Elite Ultrasound Systems running software version 14.0
- UDI(s)(01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
- Amount recalled
- 219 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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