Class II — Philips Ultrasound, LLC
| Recalling firm | Philips Ultrasound, LLC |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 |
| 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. |
| Initiated | 2026-08-07 |
| Classified | 2026-09-18 |
| Recall number | Z-3249-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Ultrasound, LLC (Z-3249-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99706/
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