

According to our records, we have delivered to you one or more devices belonging to the serial number range defined in the table below.

Palodex Group OY has identified an issue with Soredex DIGORA Optime, KaVo Scan eXam, Instrumentarium Express, and Gendex GXPS-500 Imaging Plate Systems (later called IPS). On Januthe firm distributed Urgent Medical Device Recall Communication letters by letter stating: The melting may generate smoke and eventually cause the PSU to fail. 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. Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

#New digora optime code#
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB Class 2 Device Recall DIGORA Optime (FLAT PANEL/DIGITAL IMAGER)
