Sedecal S.A.: MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Recall number

Z-1040-2015

Recalling firm

Sedecal S.A.

Product

MobileDiagnost wDR motorized portable diagnostic X-ray systems.

Status

Terminated

Initiated

2014-08-06

Posted

2015-02-02

Terminated

2016-06-22

Reason

Reports of unexpected movement.

Root cause

Other

Action

URGENT - Field Safety Notice letters dated August 6, 2014 were sent to all consignees of record. The letters instructed consignees: 1) The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop; 2) Do not try to correct unintended movement using the controls on the drive handle; 3) Instead, stop the system immediately by releasing the drive handle entirely; 4) Alternatively, the emergency button can be pressed; 5) Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur; and, 6) Should the customer feel uncertain regarding this action, he/she can contact Philips Healthcare.

Quantity

283 systems

Distribution

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 or model codes

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

510(k) numbers

["K111725"]

PMA numbers

not on file

Product code

IZL

Firm FEI

3002495042

Firm city

Algete

Firm state

not on file

Firm country

Spain

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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