Palodex Group OY

Code	Device name	Class	Specialty	Clearances	Most recent
OAS	X-Ray, Tomography, Computed, Dental	Class II	Radiology	2	2024-09-12

Date	Severity	Status	Recall #	Product	Code	Reason
2021-10-28	Class II	Ongoing	Z-2413-2024	Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray imag…	—	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 …
2020-01-07	Class II	Terminated	Z-0842-2020	Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)	—	Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which m…
2020-01-07	Class II	Terminated	Z-0841-2020	KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)	—	Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which m…
2020-01-07	Class II	Terminated	Z-0840-2020	Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)	—	Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which m…
2020-01-07	Class II	Terminated	Z-0839-2020	Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)	—	Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which m…

Date	K-number	Device	Code	Class	Specialty
2024-09-12	K241249	Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)	OAS	Class II	Radiology
2023-06-09	K230505	Orthopantomograph OP 3D LX	OAS	Class II	Radiology

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