FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2413-2024
·
Reported August 21, 2024
Enforcement
- Recall Number
- Z-2413-2024
- Event ID
- 95017
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Palodex Group Oy
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- October 28, 2021
- Classification Date
- August 12, 2024
- Address
- Nahkelantie 160, Tuusula, N/A, Finland
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
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 Info
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Distribution
US Nationwide-Worldwide
Quantity
103