eco-x series

HDX WILL CORP. · Model eco-x-s · UDI-DI 08800005200205

OAS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, and oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions. In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

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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Data 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.