Orthopantomograph OP300 dental computed tomography x-ray system — Class II medical device recall Z-2413-2024
Ongoing recall by Palodex Group Oy, reported 2024-08-21, distributed nationwide. It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC re
| Recall number | Z-2413-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Palodex Group Oy, Tuusula, Finland |
| Recall initiated | 2021-10-28 |
| Classified | 2024-08-12 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 103 |
| UPC / GTIN / UDI-DI | 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770 |
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.
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 (repeatability within 4%).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2413-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.