Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images
FDA device recall Z-2413-2024 · posted 2024-08-12 · Open, Classified
Recall details
- Recalling firm
- Palodex Group Oy
- 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%).
- Action taken
- Palodex Group Oy is preparing a Class IlIl field correction to update the firmware of ORTHOPANTOMOGRAPH OP 3D Pro of the 27 defective units and these devices will be retested for Pan ADC reproducibility. All affected persons will be notified of this defect in accordance with 21 CFR 806.10.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OAS
- Quantity affected
- 103
- Distribution
- US Nationwide-Worldwide
- Date initiated
- 2021-10-28
- Date posted
- 2024-08-12
- Location
- Tuusula, Finland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Orthopantomograph OP300 (K163423) | Palodex Group OY | 2017-08-31 |