FDA Device recall Z-3249-2026
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 by Philips Ultrasound, citing due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3249-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-07 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
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.
Identifiers
| code_info | All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540…All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Philips Ultrasound
- Philips C9-4 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips X7-2 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips L17-5 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips OMNI III TEE Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips S4-1 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound
All Philips Ultrasound recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3249-2026%22
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