Device recall
Z-2065-2012: OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product…
FDA device recall · Class I · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2065-2012 |
|---|---|
| Recall event | 62387 |
| Product | OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic… |
| Product code | OXO |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 13, 2013 |
| 510(k) numbers | K003837 |
| 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