Device recall
Z-0703-2025: OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a…
FDA device recall · Class II · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-0703-2025 |
|---|---|
| Recall event | 95846 |
| Product | OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic… |
| Product code | OXO |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203346, K233669 |
| FEI number | 1720753 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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