Medical Device Recall: 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 i
Palodex Group Oy · October 28, 2021
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%).
Product Description
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.
Distribution
US Nationwide-Worldwide
States Affected
NATIONWIDE
Quantity Affected
103
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2413-2024
Status: ongoing
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