Palodex Group Oy recalls Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images…

Recall date

October 28, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2413-2024

FDA classification

Class II

Brand / firm

Palodex Group Oy

Sold / distributed

US Nationwide-Worldwide

Why it was recalled

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%).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.