Recall Z-2413-2024 ยท OAS X-Ray, Tomography, Computed, Dental
Palodex Group Oy
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.
| Date | Aug 12, 2024 (initiated Oct 28, 2021) |
| Status | Open, Classified |
| 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%). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 103 |
| Distribution | US Nationwide-Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163423 | Orthopantomograph OP300 Palodex Group OY, Aug 31, 2017 |