Recall Z-2413-2024— Palodex Group Oy
Class II · Ongoing
Class II FDA medical device recall by Palodex Group Oy, initiated 2021-10-28. It names one FDA 510(k) clearance: K163423. 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: 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%)..
- Recalling firm
- Palodex Group Oy
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-28
- Firm location
- Tuusula, Finland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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%).
Data sourced from openFDA. This site is unofficial and independent of the FDA.