{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "178567", "product_res_number": "Z-0839-2020", "event_date_initiated": "2020-01-07", "event_date_created": "2020-01-24", "recall_status": "Terminated", "event_date_terminated": "2024-04-15", "res_event_number": "84544", "product_code": "MQB", "k_numbers": [ "K041050" ], "product_description": "Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)", "code_info": "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", "firm_fei_number": "3005383085", "recalling_firm": "Palodex Group Oy", "address_1": "Nahkelantie 160 160 nahkelantie", "city": "Tuusula", "country": "Finland", "additional_info_contact": "358-40-5121967", "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.", "root_cause_description": "Component design/selection", "action": "On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by letter stating:\nUrgent Medical Device Correction\nDear KaVo Kerr Customer,\n\nPalodex 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.\n\nProduct\nSoredex DIGORA Optime: Serial Number Range SJ1105219 to SJ1314421\nKaVo Scan eXam: Serial Number range KJ1208178 to KJ1314403\nInstrumentarium Dental Express: Serial Number Range IJ1208217 to IJ1313309\nGendex GXPS-500: Serial Number Range GJ1209488 to GJ1311722\n\nDevices falling into these serial number ranges were delivered with PSUs having nine-digit serial numbers beginning with four digits as follows: \n1143XXXXX\n1221XXXXX\n1224XXXXX and\n1229XXXXX\n\nPlease Note: If the PSU serial number does not begin with 1143, 1221, 1224, or 1229, then no action is required. \n\nIn this letter we refer to DIGORA Optime, but instructions are applicable to all four makes listed in the table above.\n\nIssue Description\n\nSlow 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. \n\nPlease 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", "product_quantity": "297", "distribution_pattern": "US: WI and PA\n\nOUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM", "openfda": { "k_number": [ "K153318", "K081624", "K140251", "K212105", "K162178", "K191939", "K232058", "K172124", "K111312", "K221714", "K031447", "K191645", "K131211", "K243734", "K140551", "K061538", "K003256", "K222855", "K202995", "K113630", "K214030", "K052136", "K250211", "K101289", "K081963", "K111548", 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"3002819275", "3014634069", "3009532935", "8020997", "9615439", "8030112", "8030233", "3022131441", "3027605321" ], "fei_number": [ "3012624817", "3007305589", "3006542593", "3011950073", "3002088145", "1219183", "3005172103", "3013501671", "3017944270", "3009001657", "3012761544", "3012127758", "3002143662", "3004706313", "2126677", "3031503890", "3003775006", "3004077520", "1450503", "3011015597", "3008284470", "3023003446", "3011471624", "3004485675", "3009717300", "3005254598", "3002807092", "3015464948", "3002808139", "3014209556", "1000582291", "3016250464", "3001722928", "3010300212", "3006529712", "2433615", "3006551157", "1000117423", "3003202425", "3023546785", "3003528079", "1418960", "3006051164", "3003772616", "3004606964", "3007734888", "3003314115", "3013599033", "3002952981", "3003861317", "3015531968", "3005406110", "3011416394", "3021059265", "3009134655", "3012494290", "1717855", "3005560996", "3015223550", "3014544225", "3011825597", "1000181430", "3002808382", "3016256852", "3033527770", "1000114111", "3005810333", "3000126629", "3002495042", "3002885429", "1418964", "3004084693", "3017375271", "3008875470", "3032116890", "2243057", "3003377038", "3012855798", "3009715136", "3030898585", "3001556265", "3008496839", "3025442726", "3009077524", "3009529630", "3008164200", "3017585294", "3002675731", "3009963139", "3033525986", "3013186032", "3009048384", "3004977335", "3029916061", "3017403245", "3006013411", "3013714596", "3007836437", "3006115340", "3038614464", "3016674851", "3021736604", "3013688559", "3013679558", "3007065358", "3003769120", "3002175190", "3005778458", "3011347852", "3003768251", "3002807880", "3017004860", "3011158427", "3004989804", "3008787461", "1000222289", "3015276088", "3004063527", "3005116291", "2155", "3022810909", "3002819275", "1317307", "3014634069", "3009532935", "3002808461", "3022131441", "3027605321" ], "device_name": "Solid State X-Ray Imager (Flat Panel/Digital Imager)", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ] }