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

[pending] True 3D Viewer, Model: EP-00003

Pending LLM rewrite. Source: FDA_DEVICE Z-1785-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.

The recalled product

Product
True 3D Viewer, Model: EP-00003
Manufacturer
Echopixel, Inc.
Category
Medical Device — Devices

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

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