Palodex Group Oy Nahkelantie 160 Tuusula Finland 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Palodex Group Oy Nahkelantie 160 Tuusula Finland
Lot Codes / Batch Numbers
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Products Sold
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Palodex Group Oy Nahkelantie 160 Tuusula Finland is recalling Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventi due to 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 resu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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%).
Recommended Action
Per FDA guidance
Palodex Group Oy is preparing a Class IlIl field correction to update the firmware of ORTHOPANTOMOGRAPH OP 3D Pro of the 27 defective units and these devices will be retested for Pan ADC reproducibility. All affected persons will be notified of this defect in accordance with 21 CFR 806.10.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026