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Palodex Group Oy
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Palodex Group Oy and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-08-21FDA-DeviceClass IIOrthopantomograph 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.
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%).
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