Sedecal S.A.: Medical Device Recall in 2015 - (Recall #: Z-1040-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Product Classification:

Class II

Date Initiated: August 6, 2014
Date Posted: February 11, 2015
Recall Number: Z-1040-2015
Event ID: 70237
Reason for Recall:

Reports of unexpected movement.

Status: Terminated
Product Quantity: 283 systems
Code Information:

Serial Numbers: 12000166 , 13000046 , 13000047 , 13000048 , 13000049 , 13000053 , 13000054 , 13000055 , 13000056 , 13000057 , 13000058 , 13000060 , 13000064 , 13000070 , 13000071 , 13000071 , 13000075 , 13000077 , 13000078 , 13000079 , 13000085 , 13000090 , 13000092 , 13000093 , 13000094 , 13000109 , 13000117 , 13000127 , 13000139 , 13000140 , 13000141 , 13000142 , 13000143 , 13000144 , 13000145 , 13000158 , 13000167 , 13000168 , 13000169 , 13000196 , 13000199 , 13000200 , 13000201 , 13000202 , 13000203 , 13000204 , 13000205 , 14000004 , 14000005 , 14000006 , 14000008 , 14000009 , 14000010 , 14000011 , 14000013 , 14000014 , 14000015 , 14000016 , 14000017 , 14000019 , 14000024 , 14000026 , 14000029 , 14000031 , 14000032 , 14000033 , 14000034 , 14000037 , 14000038 , 14000041 , 14000043 , 14000046 , 14000047 , 14000048 , 14000049 , 14000050 , 14000051 , 14000052 , 14000069 , 14000072 , 14000075 , 14000077 , 14000078 , 14000079 , 14000080 , 14000081 , 14000082 , 14000083 , 14000084 , 14000085 , 14000086 , 14000087 , 14000088 , 14000089 , 14000103 , 14000106 , 14000109 , 14000112 , 14000116 , 13000163, 13000165, 13000177, 14000022, 14000028, 485059/SN11000013 , 485060/SN11000015 , 485061/SN11000012 , 485062/SN11000009 , 488169/SN11000011 , 488171/SN11000068 , 489088/SN11000040 , 489089/SN11000016 , 489616/SN11000033 , 489694/SN11000035 , 489695/SN11000036 , 489696/SN11000037 , 490027/SN11000034 , 490221/SN11000039 , 492417/SN11000048 , 493364/SN12000022 , 493462/SN12000023 , 493565/SN11000048 , 493566/SN11000047 , 494060/SN11000070 , 494061/SN11000071 , 494062/SN11000072 , 494063/SN11000073 , 494064/SN11000074 , 494065/SN11000075 , 494456/SN11000055 , 494464/SN11000065 , 494864/SN11000060 , 494865/SN11000056 , 494866/SN11000062 , 494867/SN11000051 , 495286/SN11000061 , 495938/SN12000007 , 495939/SN12000008 , 496387/SN12000003 , 496401/SN12000059 , 496446/SN11000082 , 497572/SN12000112 , 497715/SN11000080 , 500466/SN12000045 , 500467/SN12000060 , 500468/SN12000058 , 501028/SN12000026 , 502025/SN12000124 , 502026/SN12000125 , 502424/SN12000034 , 502721/SN12000047 , 503141/SN12000038 , 503142/SN12000037 , 503143/SN12000036 , 503144/SN12000039 , 503380/SN12000044 , 503541/SN12000040 , 504450/SN12000064 , 505077/SN12000048 , 507607/SN12000054 , 507906/SN12000055 , 508342/SN12000057 , 508532/SN12000062 , 508699/SN12000088 , 508783/SN12000108 , 508838/SN12000061 , 509062/SN12000107 , 509633/SN12000069 , 509640/SN12000071 , 510607/SN12000072 , 512160/SN12000077 , 512887/SN12000085 , 512888/SN12000086 , 512890/SN12000087 , 512892/SN12000082 , 513477/SN12000080 , 513478/SN12000081 , 513848/SN12000084 , 514103/SN12000092 , 514104/SN12000091 , 514461/SN12000090 , 514462/SN12000089 , 516891/SN12000110 , 516896/SN12000111 , 518135/SN12000118 , 518342/SN12000119 , 518343/SN12000120 , 518344/SN12000121 , 518345/SN12000122 , 518346/SN12000123 , 519326/SN13000005 , 519387/SN13000012 , 519388/SN13000006 , 519434/SN13000014 , 519506/SN13000011 , 519511/SN13000010 , 519598/SN13000118 , 519599/SN13000119 , 519600/SN13000120 , 519762/SN13000018 , 519763/SN13000013 , 520251/SN13000016 , 520252/SN13000027 , 520253/SN13000017 , 520254/SN13000019 , 520255/SN13000020 , 520256/SN13000021 , 520413/SN13000023 , 520414/SN13000025 , 520415/SN13000026 , 520416/SN13000031 , 520417/SN13000033 , 520418/SN13000030 , 520422/SN13000028 , 522633/SN13000035 , 522944/SN13000037 , 523279/SN13000042 , 523349/SN13000043 , 13000067, 506626/SN12000051, 497570/SN11000066, 509718/SN12000068, 494941/SN11000052, 500740/SN12000028, 500739/SN12000027, SN11000007 , SN13000059 , SN13000059 , SN13000060 , SN13000061 , SN13000069 , SN13000072 , SN13000073 , SN13000074 , SN13000080 , SN13000082 , SN13000083 , SN13000084 , SN13000087 , SN13000089 , SN13000091 , SN13000095 , SN13000096 , SN13000097 , SN13000098 , SN13000099 , SN13000100 , SN13000101 , SN13000102 , SN13000103 , SN13000104 , SN13000106 , SN13000107 , SN13000112 , SN13000113 , SN13000125 , SN13000146 , SN13000147 , SN13000148 , SN13000149 , SN13000153 , SN13000154 , SN13000157 , SN13000160 , SN13000164 , SN13000170 , SN13000174 , SN13000176 , SN13000179 , SN13000180 , SN13000181 , SN13000182 , SN13000183 , SN13000185 , SN13000206 , SN14000061 , SN14000096 , SN14000097 , SN14000098 , SN14000099 , SN14000100

Distribution Pattern:

US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI)

Voluntary or Mandated:

Voluntary: Firm initiated