# FDA recall Z-2413-2024

> **Palodex Group Oy** · Class II · device recall initiated 2021-10-28.

## 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.

## 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%).

## Distribution

US Nationwide-Worldwide

## Key facts

- **Recall number:** Z-2413-2024
- **Recalling firm:** Palodex Group Oy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-28
- **Report date:** 2024-08-21

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Tuusula, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2413-2024

## Citation

> AI Analytics. FDA recall Z-2413-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2413-2024. Source: US FDA. Licensed CC0.

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