Class II — Echopixel, Inc.
| Recalling firm | EchoPixel, Inc. |
|---|---|
| Registered facility | ECHOPIXEL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | True 3D Viewer, Model: EP-00003 |
| Quantity | 18 |
| 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. |
| Initiated | 2018-02-21 |
| Classified | 2025-05-16 |
| Recall number | Z-1785-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Echopixel, Inc. (Z-1785-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96674/
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