Z-3249-2026Class II

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Name: Z-3249-2026 Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Creator: Philips Ultrasound, LLC
Published: 2026-08-07
License: https://open.fda.gov/license/

Philips Ultrasound, LLC / initiated 2026-08-07 / Open, Classified

FDA source

Recall record

Recall number: Z-3249-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-07
Posted: 2026-09-18
Recalling firm: Philips Ultrasound, LLC
Product: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
FDA root cause: Software Design Change
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.
Quantity in commerce: 219 units
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 codes and lots: All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3249-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3249-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)