True 3D Viewer — Class II medical device recall Z-1785-2025
Ongoing recall by Echopixel, Inc., reported 2025-05-28, distributed nationwide. With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer,
| Recall number | Z-1785-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Echopixel, Inc., San Jose, CA, United States |
| Recall initiated | 2018-02-21 |
| Classified | 2025-05-16 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00851325007003 |
| Model numbers | EP-00003 |
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.
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-1785-2025. 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.