Device recall
Z-1807-2025: TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and…
FDA device recall · Class II · Echopixel, Inc.
Key facts
| Recall number (Z-number) | Z-1807-2025 |
|---|---|
| Recall event | 96629 |
| 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… |
| Product code | LLZ |
| Recalling firm | Echopixel, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K142107 |
| FEI number | 3011501361 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database