Class II — Echopixel, Inc.
| Recalling firm | EchoPixel, Inc. |
|---|---|
| Registered facility | ECHOPIXEL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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 compri… |
| Quantity | 9 systems |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada. |
| Initiated | 2016-04-11 |
| Classified | 2025-05-21 |
| Recall number | Z-1807-2025 |
| 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-1807-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96629/
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