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PaX-i3D Green Premium / Green 21
VATECH CO., LTD. · Model PCT-90LH · UDI-DI 08800016400359
OAS
Prescription
10
510(k) clearances
7
Adverse events
7
Recalls
48
Facilities
Description
Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray Image data (Xmaru3104CF)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta |
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta |
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta |
| 2021-10-28 | Palodex Group Oy | 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 accep |
| 2021-07-21 | Trophy SAS | Device failed to function as intended and/or failed to conform to their design specifications. |
| 2018-12-31 | KaVo Dental Technologies LLC | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 |
| 2015-08-05 | Villa Radiology Systems LLC | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.