# FDA recall Z-1785-2025

> **Echopixel, Inc.** · Class II · device recall initiated 2018-02-21.

## Product

True 3D Viewer, Model: EP-00003

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.

## Key facts

- **Recall number:** Z-1785-2025
- **Recalling firm:** Echopixel, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-02-21
- **Report date:** 2025-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2025

## Citation

> AI Analytics. FDA recall Z-1785-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1785-2025. Source: US FDA. Licensed CC0.

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