FDA Device recall Z-0839-2020

Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

FDA Device
Class II
terminated
Published 2020-01-29

On 2020-01-29 the FDA classified a Class II recall of Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) by Palodex Group Oy, citing 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 an….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0839-2020
Classification	Class II
Status	terminated
Initiated	2020-01-07
Published	2020-01-29
Last updated	2026-09-13 11:55 UTC
Company	Palodex Group Oy
Distribution	PA, WI

Product

Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Reason

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.

Identifiers

code_info	Serial Number: SJ1208232, SJ1208233, SJ1208234, SJ1208235, SJ1208236, SJ1208238, SJ1208248, SJ1208249, SJ1208251, SJ120… Serial Number: SJ1208232, SJ1208233, SJ1208234, SJ1208235, SJ1208236, SJ1208238, SJ1208248, SJ1208249, SJ1208251, SJ1208252, SJ1208253, SJ1208254, SJ1208255, SJ1208256, SJ1208257, SJ1208268, SJ1208269, SJ1208270, SJ1208296, SJ1208297, SJ1208298, SJ1208299, SJ1208300, SJ1208301, SJ1208303, SJ1208304, SJ1208305, SJ1208306, SJ1208307, SJ1208309, SJ1208409, SJ1208415, SJ1208416, SJ1208417, SJ1208418, SJ1208421, SJ1208431, SJ1208433, SJ1208434, SJ1208436, SJ1208437, SJ1208439, SJ1208440, SJ1208441, SJ1208442, SJ1208446, SJ1208447, SJ1208449, SJ1208451, SJ1208452, SJ1208453, SJ1208454, SJ1208455, SJ1208456, SJ1208457, SJ1208460, SJ1208461, SJ1208462, SJ1208465, SJ1208519, SJ1208523, SJ1208524, SJ1208533, SJ1208534, SJ1208535, SJ1208536, SJ1208537, SJ1208538, SJ1208556, SJ1208558, SJ1208559, SJ1208560, SJ1208561, SJ1208563, SJ1208571, SJ1208572, SJ1208573, SJ1208574, SJ1208575, SJ1208577, SJ1208578, SJ1208579, SJ1208580, SJ1208581, SJ1208583, SJ1208584, SJ1208585, SJ1208586, SJ1208588, SJ1208

code_info

Serial Number: SJ1208232, SJ1208233, SJ1208234, SJ1208235, SJ1208236, SJ1208238, SJ1208248, SJ1208249, SJ1208251, SJ120…

Serial Number: SJ1208232, SJ1208233, SJ1208234, SJ1208235, SJ1208236, SJ1208238, SJ1208248, SJ1208249, SJ1208251, SJ1208252, SJ1208253, SJ1208254, SJ1208255, SJ1208256, SJ1208257, SJ1208268, SJ1208269, SJ1208270, SJ1208296, SJ1208297, SJ1208298, SJ1208299, SJ1208300, SJ1208301, SJ1208303, SJ1208304, SJ1208305, SJ1208306, SJ1208307, SJ1208309, SJ1208409, SJ1208415, SJ1208416, SJ1208417, SJ1208418, SJ1208421, SJ1208431, SJ1208433, SJ1208434, SJ1208436, SJ1208437, SJ1208439, SJ1208440, SJ1208441, SJ1208442, SJ1208446, SJ1208447, SJ1208449, SJ1208451, SJ1208452, SJ1208453, SJ1208454, SJ1208455, SJ1208456, SJ1208457, SJ1208460, SJ1208461, SJ1208462, SJ1208465, SJ1208519, SJ1208523, SJ1208524, SJ1208533, SJ1208534, SJ1208535, SJ1208536, SJ1208537, SJ1208538, SJ1208556, SJ1208558, SJ1208559, SJ1208560, SJ1208561, SJ1208563, SJ1208571, SJ1208572, SJ1208573, SJ1208574, SJ1208575, SJ1208577, SJ1208578, SJ1208579, SJ1208580, SJ1208581, SJ1208583, SJ1208584, SJ1208585, SJ1208586, SJ1208588, SJ1208

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0839-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.