EPIQ Elite Diagnostic Ultrasound System recallZ-3249-2026 · Philips Ultrasound, LLC · initiated Aug 7, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Ultrasound, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software Design Change
What the company is doing
On August 7, 2026, Philips issued a Urgent Medical Device Correction Notification to affected consignees. Philips requested consignees take the following actions: 1. Due to possibility of a weak PW Doppler Signal on EPIQ Elite running 14.0 SW, customers are advised not to use C5-1 Abd Vasc Tissue Specific Preset (TSP). Please use a different TSP (e.g., Abd Gen, Abd Renal) within C5-1. Please note that this issue (i.e., Weak PW Doppler signal) is restricted to the Abd Vasc TSP with C5-1 on EPIQ Elite running SW 14.0 only. 2. Otherwise, you may continue to use your device in accordance with the IFU. 3.Circulate this notice to all users of the device so that they are aware of the product issue and associated hazard / harm. 4. Post this notice near the affected unit(s) for ease of reference 5. Please return the completed response form at the end of this notice, indicating that information on this issue has been read and understood. Philips asks that you return the completed response form no later than 30 days from receipt of this letter.
Recall details
- Recall number
- Z-3249-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 7, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Philips Ultrasound, LLC
- Quantity
- 219 units
- Product code
- IYN
- FDA submissions
- K260123, K260680
- 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.
Product description
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Code information (models, lots, serial numbers)
All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- EPIQ Elite Diagnostic Ultrasound System 795234Philips Ultrasound LLC · System, Image Processing, Radiological3 recalls39 reports
- EPIQ Elite Diagnostic Ultrasound System 795234Philips Ultrasound LLC · System, Imaging, Pulsed Doppler, Ultrasonic1 recall17 reports
- EPIQ Elite Diagnostic Ultrasound System 795234Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic1 recall14 reports
- EPIQ Elite Diagnostic Ultrasound System 795234Philips Ultrasound LLC · System, Imaging, Pulsed Doppler, Ultrasonic1 recall3 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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