Device recall
Z-0975-2017: The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic…
FDA device recall · Class II · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-0975-2017 |
|---|---|
| Recall event | 76033 |
| Product | The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac… |
| Product code | OXO |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2017 |
| 510(k) numbers | K120613, K122234 |
| 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