Model note · Ultrasound
Philips EPIQ Series diagnostic ultrasound
The EPIQ series is the Philips EPIQ ultrasound family. It covers general imaging, women's health and cardiology, including TEE and intracardiac echo, and works with EchoNavigator for fusion with live X-ray in structural heart procedures. Philips files a new 510(k) for almost every software release, at least ten between 2025 and 2026, so features and fixes follow the software version. The recall record mixes mechanical faults (control panel arm screws and swivel lock), transducer faults (a 3D9-3v chassis coming apart, TEE probes not measuring tip temperature, X5-1c damage from reboots) and software faults that give wrong measurements or delayed images.
The model
Maker, model and type.
- Maker
- Philips Ultrasound, LLC
- Model
- EPIQ Series diagnostic ultrasound (EPIQ 5, EPIQ 7, EPIQ Elite, EPIQ CVx/CVxi)
- Device type
- Ultrasound
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification | Ultrasonic pulsed Doppler imaging system, 21 CFR 892.1550, product code IYN; recent clearances include K251455 (24 July 2025, SVS v2 Contrast) and K262548 (25 September 2026) | Source |
| Modes | B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging | Source |
| Indications | Abdominal, adult, pediatric and fetal cardiac, cerebral vascular, cephalic, obstetric, gynaecological, intraoperative, intraluminal, intracardiac echo, musculoskeletal, ophthalmic, urology, pediatric, peripheral vessel, small organ, TEE, transrectal, transvaginal, lung | Source |
| Models on software 13 | EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5 (with the Affiniti family on VM13.0) | Source |
| Model numbers named in recalls | EPIQ 7G 795200, 7C 795201, 7W 795202, 5G 795204, CVxi 795232, Elite 795234 | Source |
| AI functions | SVS v2 Contrast picks images for LV analysis using a deep learning view classifier plus a non AI selection rule; the user can override | Source |
Recalls
Known FDA recalls.
- Z-3249-20262026-08-07
EPIQ Elite: Doppler sample shown shallower than its actual location (219 units).
FDA record - Z-0283-20242023-10-09
Software 10.0 may show a delayed image instead of real time (83 systems).
FDA record - Z-2517-20232023-06-30
3D9-3v transducer chassis may come apart (449 units).
FDA record - Z-1007-20262022-07-14
Unexpected reboot can damage the X5-1c transducer (1,721 systems).
FDA record - Z-2306-20212021-07-22
Control panel arm swivel lock could fail.
FDA record - Z-1841-20202019-08-30
S7-3t TEE probes not programmed correctly could not measure tip temperature or start auto cool.
FDA record
Safety
Safety warnings from the record.
- A separated transducer chassis can expose the patient or user to tissue damage and, if other protections fail, electric shock. Source
- A TEE probe that does not start auto cool can overheat at the tip and injure the patient. Source
- Several software versions mis filed images or patient data in uncommon workflows; check patient identity on each exam. Source
Sources
Where this note comes from.
- FDA 510(k) K251455 summary, EPIQ and Affiniti Series (SVS v2 Contrast)
- openFDA 510(k) records for EPIQ
- openFDA device recall records for EPIQ
Not covered: The EPIQ user and service manuals were not read, so acoustic output limits, the transducer list, power and network specifications and system error codes are not included. MAUDE problem counts were not used because the EPIQ brand name is shared across many models. The phantom check in the design note is BMEssentia advice drawn from the recall pattern.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Ultrasound