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Recall Observatory FDA recall evidence

Device 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.

Z-2413-2024

October 28, 2021

Class II

Product summary

Firm
Palodex Group Oy
Event
Event 95017
Status
Ongoing
Classification
Class II
Quantity
103
Official record key
device-enforcement:Z-2413-2024

Official wording

Reason: 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%).

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

Distribution pattern: US Nationwide-Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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%).