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Palodex Group Oy Recalls
5 recalls on record · January 29, 2020 to August 21, 2024 · Medical Devices
Recalls by year
20
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 21, 2024Medical DevicesFDA
Palodex Group Oy recalls Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray imag
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%).
January 29, 2020Medical DevicesFDA
Palodex Group Oy recalls Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Hazard: 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 may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
January 29, 2020Medical DevicesFDA
Palodex Group Oy recalls KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Hazard: 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 may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
January 29, 2020Medical DevicesFDA
Palodex Group Oy recalls Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Hazard: 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 may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
January 29, 2020Medical DevicesFDA
Palodex Group Oy recalls Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Hazard: 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 may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.