Class II — Palodex Group Oy
| Recalling firm | PaloDEx Group Oy |
|---|---|
| Registered facility | PALODEX GROUP OY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 (repeatability within 4%). |
| Product | 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 operated and used by qualified healthcare professionals. |
| Quantity | 103 |
| Distribution | US Nationwide-Worldwide |
| Initiated | 2021-10-28 |
| Classified | 2024-08-12 |
| Recall number | Z-2413-2024 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Palodex Group Oy (Z-2413-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95017/
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