FDAFDA · Food and drugs·Recall number Z-2413-2024
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.
Published August 21, 2024 · Recall initiated: October 28, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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%).
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Palodex Group Oy
- Distributor
- US Nationwide-Worldwide
- Lot
- DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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