Palodex Group Oy: Medical Device Recall in 2024 - (Recall #: Z-2413-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 28, 2021

Date Posted: August 21, 2024

Recall Number: Z-2413-2024

Event ID: 95017

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%).

Status: Ongoing

Product Quantity: 103

Code Information:

DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770

Distribution Pattern:

US Nationwide-Worldwide

Voluntary or Mandated:

FDA Mandated