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.
FDA Recall Z-2413-2024 · Posted 2024-08-12
Advertisement
Recalling FirmPalodex Group Oy
Recall StatusOpen, Classified
Product CodeOAS
Date Initiated2021-10-28
Product Quantity103
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%).
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide-Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement