CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Philips EPIQ Elite Diagnostic Ultrasound System recalled
Philips Ultrasound is recalling Philips EPIQ Elite Diagnostic Ultrasound System, distributed nationwide in the US. The recall was initiated on 7 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3249-2026
- FDA event ID
- 99706
- Recalling firm
- Philips Ultrasound, Bothell, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Aug 2026
- FDA classified
- 18 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 7 Aug 2026 | Recall initiated by company | |
| 18 Sep 2026 | Classified by FDA | +42 days |
| 30 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Where it was distributed
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.
Nationwide AlabamaCaliforniaConnecticutFloridaGeorgiaKansasMarylandMinnesotaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennesseeTexasVirginiaWashingtonWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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