ORTHOPANTOMOGRAPH OP 3D Pro recallZ-2413-2024 · Palodex Group Oy · initiated Oct 28, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Palodex Group Oy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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%).
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-2413-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 28, 2021
- Posted by the FDA
- Aug 12, 2024
- Recalling firm
- Palodex Group Oy
- Quantity
- 103
- Product code
- OAS
- FDA submissions
- K163423
- Distribution
- US Nationwide-Worldwide
Product description
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.
Code information (models, lots, serial numbers)
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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