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ORTHOPANTOMOGRAPH OP 3D ProRecalls & reported problems across all models

PaloDEx Group Oy · 6 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names at least one ORTHOPANTOMOGRAPH OP 3D Pro model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
1

We found 6 models of ORTHOPANTOMOGRAPH OP 3D Pro by PaloDEx Group Oy in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ORTHOPANTOMOGRAPH OP 3D Pro recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Oct 28, 2021Open, Classified

    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%).

    Z-2413-2024 · Root cause: Radiation Control for Health and Safety Act · names 6 of these models · Recall details · FDA record ↗

ORTHOPANTOMOGRAPH OP 3D Pro models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page