Z-2413-2024Class II

Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D...

Name: Z-2413-2024 Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D...
Creator: Palodex Group Oy
Published: 2021-10-28
License: https://open.fda.gov/license/

Palodex Group Oy / initiated 2021-10-28 / Open, Classified / root cause: manufacturing process

FDA source

Palodex Group Oy began a recall of Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the... on 2021-10-28. FDA classified it as Class II and gives the reason as "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%)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2413-2024
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-28
Posted: 2024-08-12
Recalling firm: Palodex Group Oy
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.
Product code: OAS X-Ray, Tomography, Computed, Dental
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%).
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2413-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2413-2024	Class II	Ongoing	FDA Mandated	2024-08-21	2024-08-12

Product code OAS

K163423Class IIOrthopantomograph OP300Palodex Group OY / cleared 2017-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)