🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: January 7, 2020 Palodex Group Oy Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Palodex Group Oy
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot 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, SJ1314368 PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX

Distribution:

Distributed in: US, WI, PA, OF

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0839-2020

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