FDA Medical Device Recalls (openFDA)
Philips Ultrasound, LLC: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- Recall number
- Z-3249-2026
- Recalling firm
- Philips Ultrasound, LLC
- Product
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- Status
- Open, Classified
- Initiated
- 2026-08-07
- Posted
- 2026-09-18
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
- 510(k) numbers
- K260123, K260680
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3019216
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28