Drug recall
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor…
FDA recall event 82694 · Class II · KaVo Dental Technologies LLC
Key facts
| Event ID | 82694 |
|---|---|
| Recall numbers | Z-1387-2019 |
| Recalling firm | KaVo Dental Technologies LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality. |
| Initiation date | Apr 29, 2019 |
| Report date | May 29, 2019 |
| Termination date | Nov 25, 2020 |
| City | Charlotte |
| State | NC |
| Country | United States |
| FEI number | 1017522 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: