Drug recall
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D…
FDA recall event 95017 · Class II · Palodex Group Oy
Key facts
| Event ID | 95017 |
|---|---|
| Recall numbers | Z-2413-2024 |
| Recalling firm | Palodex Group Oy |
| Product type | Devices |
| Products | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria… |
| Initiation date | Oct 28, 2021 |
| Report date | Aug 21, 2024 |
| City | Tuusula |
| Country | Finland |
| FEI number | 3005383085 |
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: