Z-2413-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2024
- Initiation Date
- October 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 103
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%).
Distribution Pattern
US Nationwide-Worldwide
Code Information
DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770