TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1 — Class II medical device recall Z-1807-2025
Ongoing recall by Echopixel, Inc., reported 2025-05-28, distributed nationwide. Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not c
| Recall number | Z-1807-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Echopixel, Inc., San Jose, CA, United States |
| Recall initiated | 2016-04-11 |
| Classified | 2025-05-21 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 9 systems |
| UPC / GTIN / UDI-DI | 00851325007003 |
| Model numbers | EP-00001-XX |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1807-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.