Drug recall
cone-beam CT system
FDA recall event 82045 · Class II · KaVo Dental Technologies LLC
Key facts
| Event ID | 82045 |
|---|---|
| Recall numbers | Z-1101-2019 |
| Recalling firm | KaVo Dental Technologies LLC |
| Product type | Devices |
| Products | cone-beam CT system |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 |
| Initiation date | Dec 31, 2018 |
| Report date | May 1, 2019 |
| 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: