Device 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.
Z-2413-2024
Product summary
- Firm
- Palodex Group Oy
- Event
- Event 95017
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 103
- Official record key
device-enforcement:Z-2413-2024
Official wording
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%).
Code information: DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Distribution pattern: US Nationwide-Worldwide
Derived failure modes
-
Unknown
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%).