Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device Recalled by Palodex Group Oy Due to It was noticed in production on 28.10.2021, that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Palodex Group Oy directly.
Affected 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.
Quantity: 103
Why Was This 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%).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Palodex Group Oy
Palodex Group Oy has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report