The Recall Desk
HighFDA (Devices)·Z-1785-2025·Announced 2025-05-28

True 3D Viewer Model EP-00003 Software Orientation Display Issue Recall

Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving risk of harm (misdiagnosis and incorrect surgical treatment) where no injuries have yet been reported. The defect concerns imaging orientation accuracy, a critical safety function in medical imaging.

Plain-English summary

Echopixel, Inc. is recalling the True 3D Viewer, Model EP-00003, due to a software defect affecting certain versions of the application. When importing enhanced ultrasound formatted data or ultrasound images into the 3D viewer for digital image processing, review, analysis, communication, and media interchange from CT, MRI, or ultrasound sources, the software can display image orientation incorrectly.

This orientation error could result in clinicians making incorrect diagnoses or developing incorrect surgical treatment plans based on the misrepresented imaging data.

The affected software versions include full release versions 1.6.1.3080.428 (released 13-Apr-2017) and 1.6.2.3670.435 (released 07-Dec-2017), as well as multiple develop versions for research use released between 15-Feb-2017 and 11-Jan-2018. The device is identified by UDI-DI: 00851325007003. Distribution includes nationwide availability in California, Ohio, New Jersey, Pennsylvania, Massachusetts, Florida, Connecticut, Texas, Louisiana, and Michigan, as well as Minnesota and Canada.

Customers using affected software versions should verify correct image orientation before making any clinical decisions. Facility administrators should contact Echopixel, Inc. for information regarding software updates or mitigation measures.

The recalled product

Product
True 3D Viewer, Model: EP-00003
Manufacturer
Echopixel, Inc.
Category
Medical Device — Diagnostic Imaging Software
Hazard
  • image-orientation-error
  • misdiagnosis-risk
  • incorrect-surgical-planning

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • UDI-DI: 00851325007003. Full release software versions: 1.6.1.3080.428
  • released 13-Apr-2017 1.6.2.3670.435
  • released 07-Dec-2017 Develop Versions
  • for research use: 0.00.2695.422
  • released 15-Feb-2017 0.00.2927.423
  • released 15-Feb-2017 0.00.2964.423
  • released 24-Feb-2017 0.00.3102.428
  • released 04-Apr-2017 0.00.3245.428
  • released 05-May-2017 0.00.3302.431
  • released 02-Jun-2017 0.00.3344.432
  • released 18-Jul-2017 0.00.3412.433
  • released 14-Aug-2017 0.00.3656.442
  • released 09-Nov-2017 0.00.3669.442
  • released 05-Dec-2017 0.00.3683.445
  • released 02-Jan-2018 0.00.3702.447
  • released 11-Jan-2018 0.00.3730.447
  • released 08-Feb-2018

Distribution

Distributed nationwide across the United States.

Related recalls

Same category