Philips Ultrasound recall: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound, LLC is recalling Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 – 219 units. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 7, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 |
| Brand | Philips Ultrasound |
| Company | Philips Ultrasound, LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 7, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 219 units |
| Recall ID | 99706 |
Recalled products
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- FDA recall number
- Z-3249-2026
- Codes, lots 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
- Quantity
- 219 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99706
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Bothell, WA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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 to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99706, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Philips Ultrasound Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recalled?
Yes. Philips Ultrasound, LLC recalled it on August 7, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.