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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOPANTOMOGRAPHTM OP 3D Pro

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 Class 2 Device Recall ORTHOPANTOMOGRAPHTM OP 3D Prosee related information
Date Initiated by FirmOctober 28, 2021
Date PostedAugust 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2413-2024
Recall Event ID 95017
510(K)NumberK163423 
Product Classification X-ray, tomography, computed, dental - Product Code OAS
ProductOrthopantomograph 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 DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Recalling Firm/
Manufacturer
Palodex Group Oy
Nahkelantie 160
Tuusula Finland
For Additional Information ContactErika Martin
40-512 1967
Manufacturer 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%).
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
ActionPalodex 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.
Quantity in Commerce103
DistributionUS Nationwide-Worldwide
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OAS
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