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.
This recall is currently active, issued August 12, 2024. It was issued by Palodex Group Oy Nahkelantie 160 Tuusula Finland.
- Recall Initiated
- October 28, 2021
- Posted
- August 12, 2024
- Recall Number
- Z-2413-2024
- Quantity
- 103
- Official Source
- View on FDA website ↗
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%).
Distribution
US Nationwide-Worldwide
Lot / Code Info
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.