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Palodex Group Oy recalls Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray imag
Recalled August 21, 2024 · FDA recall Z-2413-2024 · 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%). · FDA Class II
Units
103
Sold at
US Nationwide-Worldwide
Description
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%).
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.
Manufacturer(s)
Palodex Group Oy
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →