Date Initiated by Firm | October 28, 2021 |
Date Posted | August 12, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2413-2024 |
Recall Event ID |
95017 |
510(K)Number | K163423 |
Product Classification |
X-ray, tomography, computed, dental - Product Code OAS
|
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. |
Code Information |
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756,
06430035872763, 06430035872770 |
Recalling Firm/ Manufacturer |
Palodex Group Oy Nahkelantie 160 Tuusula Finland
|
For Additional Information Contact | Erika 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 |
Action | 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. |
Quantity in Commerce | 103 |
Distribution | US Nationwide-Worldwide |
Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = OAS
|