Device recall
Z-1387-2019: DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral…
FDA device recall · Class II · KaVo Dental Technologies LLC
Key facts
| Recall number (Z-number) | Z-1387-2019 |
|---|---|
| Recall event | 82694 |
| Product | DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the… |
| Product code | MUH |
| Recalling firm | KaVo Dental Technologies LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2020 |
| 510(k) numbers | K172918 |
| FEI number | 1017522 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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