Device recall
Z-0009-2015: eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA…
FDA device recall · Class II · Gendex Corp
Key facts
| Recall number (Z-number) | Z-0009-2015 |
|---|---|
| Recall event | 69064 |
| Product | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy… |
| Product code | EHD |
| Recalling firm | Gendex Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2017 |
| 510(k) numbers | K992610 |
| FEI number | 3009212242 |
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