Device recall
Z-2040-2011: Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with…
FDA device recall · Class II · Gendex Dental Systems
Key facts
| Recall number (Z-number) | Z-2040-2011 |
|---|---|
| Recall event | 57888 |
| Product | Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the… |
| Product code | EHD |
| Recalling firm | Gendex Dental Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2012 |
| 510(k) numbers | K050255 |
| FEI number | 3004115000 |
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