Recall Z-3249-2026— Philips Ultrasound, LLC
Class II · Ongoing
Class II FDA medical device recall by Philips Ultrasound, LLC, initiated 2026-08-07. It names 2 FDA 510(k) clearances: K260123, K260680. Product: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234. 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..
- Recalling firm
- Philips Ultrasound, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-07
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
2 on FDA's record- K260123 — EPIQ Series Diagnostic Ultrasound System
- K260680 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.