FDA Device recall Z-2413-2024
Orthopantomograph OP300 dental computed tomography x-ray system
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Orthopantomograph OP300 dental computed tomography x-ray system by Palodex Group Oy, citing 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 acce….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2413-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-28 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Palodex Group Oy |
| Distribution | US |
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
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%).
Identifiers
| code_info | DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2413-2024%22
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