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.
Check against the official notice below — it lists the full affected range.
Palodex Group Oy is recalling 103 Orthopantomograph OP300 dental computed tomography x-ray systems distributed nationwide and worldwide. On October 28, 2021, a defect was discovered in production where the final testing database was incorrectly approving units that failed the Pan ADC repeatability test, which should maintain results within 4% accuracy. The affected devices are identified by specific device identification numbers: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, and 06430035872770.
The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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%).
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 Quantity: 103 Lot/code info: DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.