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Open, Classified

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

FDA Recall Z-3249-2026 · Posted 2026-09-18

Recalling FirmPhilips Ultrasound, LLC
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2026-08-07
Product Quantity219 units

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.

Firm Action

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.

Root Cause

Software Design Change

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026-05-27K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · 2026-05-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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