# FDA recall Z-1807-2025

> **Echopixel, Inc.** · Class II · device recall initiated 2016-04-11.

## Product

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX    Software versions 1.0, 1.25, and 1.35    The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions.    The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making.  The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

## Reason for recall

Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.

## Key facts

- **Recall number:** Z-1807-2025
- **Recalling firm:** Echopixel, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2016-04-11
- **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-1807-2025

## Citation

> AI Analytics. FDA recall Z-1807-2025. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1807-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*