FDAFDA · Food and drugs·Recall number Z-1040-2015
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Published February 11, 2015 · Recall initiated: August 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of unexpected movement.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sedecal S.A.
- Distributor
- 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)
- Lot
- 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 , SN130000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Spain
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