FDA-Device2024-08-21Class II
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.
Palodex Group Oy
Hazard
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%).
Sold states
US Nationwide-Worldwide
Affected count
103
Manufactured in
Nahkelantie 160, Tuusula, Finland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2413-2024Don't want to check this manually?
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