Palodex Group Oy Nahkelantie 160 Tuusula Finland Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Brand
Palodex Group Oy Nahkelantie 160 Tuusula Finland
Lot Codes / Batch Numbers
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, SJ1208596, SJ1208597, SJ1208598, SJ1208599, SJ1208600, SJ1208601, SJ1208602, SJ1208603, SJ1208604, SJ1208605, SJ1208606, SJ1208607, SJ1208608, SJ1208609, SJ1208610, SJ1210176, SJ1210177, SJ1210178, SJ1210179, SJ1210180, SJ1210181, SJ1210184, SJ1210185, SJ1210187, SJ1210188, SJ1210189, SJ1210191, SJ1210192, SJ1210193, SJ1210194, SJ1210195, SJ1210197, SJ1210200, SJ1210201, SJ1210202, SJ1210204, SJ1210205, SJ1210206, SJ1210208, SJ1210209, SJ1210210, SJ1210213, SJ1210219, SJ1210281, SJ1210282, SJ1210283, SJ1210284, SJ1210285, SJ1210287, SJ1210288, SJ1210289, SJ1210291, SJ1210292, SJ1210293, SJ1210295, SJ1210297, SJ1210298, SJ1210300, SJ1210310, SJ1210312, SJ1210313, SJ1210314, SJ1210315, SJ1210316, SJ1210317, SJ1210318, SJ1210319, SJ1210320, SJ1210322, SJ1210323, SJ1210324, SJ1210326, SJ1210398, SJ1210400, SJ1210401, SJ1210402, SJ1210404, SJ1210416, SJ1210417, SJ1210497, SJ1210499, SJ1210500, SJ1210501, SJ1210502, SJ1210503, SJ1210504, SJ1210506, SJ1210508, SJ1210511, SJ1210512, SJ1210514, SJ1210515, SJ1210528, SJ1210529, SJ1210530, SJ1210534, SJ1210535, SJ1210536, SJ1210538, SJ1210540, SJ1210541, SJ1210542, SJ1211114, SJ1211117, SJ1211118, SJ1211121, SJ1211123, SJ1211127, SJ1211129, SJ1211130, SJ1211131, SJ1211132, SJ1211133, SJ1211134, SJ1211135, SJ1211137, SJ1211138, SJ1211224, SJ1211225, SJ1211226, SJ1211227, SJ1211228, SJ1211229, SJ1211230, SJ1211231, SJ1211232, SJ1211233, SJ1211234, SJ1211235, SJ1211236, SJ1211237, SJ1211238, SJ1211239, SJ1211240, SJ1211241, SJ1211242, SJ1211243, SJ1211244, SJ1211245, SJ1211246, SJ1211247, SJ1211248, SJ1211249, SJ1211250, SJ1211251, SJ1211252, SJ1211263, SJ1211341, SJ1211343, SJ1211345, SJ1211346, SJ1211347, SJ1211348, SJ1211349, SJ1211354, SJ1211355, SJ1211356, SJ1211358, SJ1211360, SJ1211378, SJ1211379, SJ1211382, SJ1311602, SJ1311603, SJ1311605, SJ1311606, SJ1311607, SJ1311608, SJ1311609, SJ1311610, SJ1311611, SJ1311612, SJ1311613, SJ1311614, SJ1311615, SJ1311616, SJ1311617, SJ1311766, SJ1311767, SJ1311768, SJ1311769, SJ1311770, SJ1311771, SJ1311772, SJ1311774, SJ1311776, SJ1311777, SJ1311778, SJ1311779, SJ1311780, SJ1311781, SJ1311783, SJ1312271, SJ1312481, SJ1313119, SJ1313121, SJ1313122, SJ1313124, SJ1313127, SJ1313220, SJ1313223, SJ1313224, SJ1313225, SJ1313228, SJ1313230, SJ1314362, SJ1314363
Products Sold
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, SJ1208596, SJ1208597, SJ1208598, SJ1208599, SJ1208600, SJ1208601, SJ1208602, SJ1208603, SJ1208604, SJ1208605, SJ1208606, SJ1208607, SJ1208608, SJ1208609, SJ1208610, SJ1210176, SJ1210177, SJ1210178, SJ1210179, SJ1210180, SJ1210181, SJ1210184, SJ1210185, SJ1210187, SJ1210188, SJ1210189, SJ1210191, SJ1210192, SJ1210193, SJ1210194, SJ1210195, SJ1210197, SJ1210200, SJ1210201, SJ1210202, SJ1210204, SJ1210205, SJ1210206, SJ1210208, SJ1210209, SJ1210210, SJ1210213, SJ1210219, SJ1210281, SJ1210282, SJ1210283, SJ1210284, SJ1210285, SJ1210287, SJ1210288, SJ1210289, SJ1210291, SJ1210292, SJ1210293, SJ1210295, SJ1210297, SJ1210298, SJ1210300, SJ1210310, SJ1210312, SJ1210313, SJ1210314, SJ1210315, SJ1210316, SJ1210317, SJ1210318, SJ1210319, SJ1210320, SJ1210322, SJ1210323, SJ1210324, SJ1210326, SJ1210398, SJ1210400, SJ1210401, SJ1210402, SJ1210404, SJ1210416, SJ1210417, SJ1210497, SJ1210499, SJ1210500, SJ1210501, SJ1210502, SJ1210503, SJ1210504, SJ1210506, SJ1210508, SJ1210511, SJ1210512, SJ1210514, SJ1210515, SJ1210528, SJ1210529, SJ1210530, SJ1210534, SJ1210535, SJ1210536, SJ1210538, SJ1210540, SJ1210541, SJ1210542, SJ1211114, SJ1211117, SJ1211118, SJ1211121, SJ1211123, SJ1211127, SJ1211129, SJ1211130, SJ1211131, SJ1211132, SJ1211133, SJ1211134, SJ1211135, SJ1211137, SJ1211138, SJ1211224, SJ1211225, SJ1211226, SJ1211227, SJ1211228, SJ1211229, SJ1211230, SJ1211231, SJ1211232, SJ1211233, SJ1211234, SJ1211235, SJ1211236, SJ1211237, SJ1211238, SJ1211239, SJ1211240, SJ1211241, SJ1211242, SJ1211243, SJ1211244, SJ1211245, SJ1211246, SJ1211247, SJ1211248, SJ1211249, SJ1211250, SJ1211251, SJ1211252, SJ1211263, SJ1211341, SJ1211343, SJ1211345, SJ1211346, SJ1211347, SJ1211348, SJ1211349, SJ1211354, SJ1211355, SJ1211356, SJ1211358, SJ1211360, SJ1211378, SJ1211379, SJ1211382, SJ1311602, SJ1311603, SJ1311605, SJ1311606, SJ1311607, SJ1311608, SJ1311609, SJ1311610, SJ1311611, SJ1311612, SJ1311613, SJ1311614, SJ1311615, SJ1311616, SJ1311617, SJ1311766, SJ1311767, SJ1311768, SJ1311769, SJ1311770, SJ1311771, SJ1311772, SJ1311774, SJ1311776, SJ1311777, SJ1311778, SJ1311779, SJ1311780, SJ1311781, SJ1311783, SJ1312271, SJ1312481, SJ1313119, SJ1313121, SJ1313122, SJ1313124, SJ1313127, SJ1313220, SJ1313223, SJ1313224, SJ1313225, SJ1313228, SJ1313230, SJ1314362, SJ1314363, SJ1314368 PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX
Palodex Group Oy Nahkelantie 160 Tuusula Finland is recalling Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) due to 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 circuiti. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by letter stating: Urgent Medical Device Correction Dear KaVo Kerr Customer, 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). According to our records, we have delivered to you one or more devices belonging to the serial number range defined in the table below. The Power Supply Unit (PSU) delivered with the device may have a fault requiring correction. Product Soredex DIGORA Optime: Serial Number Range SJ1105219 to SJ1314421 KaVo Scan eXam: Serial Number range KJ1208178 to KJ1314403 Instrumentarium Dental Express: Serial Number Range IJ1208217 to IJ1313309 Gendex GXPS-500: Serial Number Range GJ1209488 to GJ1311722 Devices falling into these serial number ranges were delivered with PSUs having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX Please Note: If the PSU serial number does not begin with 1143, 1221, 1224, or 1229, then no action is required. In this letter we refer to DIGORA Optime, but instructions are applicable to all four makes listed in the table above. Issue Description Slow degradation of plastic insulation used in the PSU DC plug may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail. Risk of fire or injury has been assessed to be low. As a result, Palodex Group OY is being proactive with our customers to have these identified Imaging Plates Systems corrected. Please communicate this information to your local distributors and report the initiated Medical Device Correction to your local authorities if the local regulation requires distributors to do so. Palodex Group Oy as a manufacturer of the Imaging Plates Systems will take care of manufacturers reporting t
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA, WI
Page updated: Jan 10, 2026