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Recall Observatory FDA recall evidence

Device product

Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Z-1084-2016

January 18, 2016

Class II

Product summary

Firm
Sedecal S.A.
Event
Event 73428
Status
Terminated
Classification
Class II
Quantity
349 systems
Official record key
device-enforcement:Z-1084-2016

Official wording

Reason: This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.

Code information: Serial Numbers: 485886/SN11000007, 485062/SN11000009, 488169/SN11000011, 485061/SN11000012, 485059/SN11000013, 485060/SN11000015, 489089/SN11000016, 489616/SN11000033, 490027/SN11000034, 489694/SN11000035, 489695/SN11000036, 489696/SN11000037, 490221/SN11000039, 489088/SN11000040, 493566/SN11000047, 493565/SN11000048, 494867/SN11000051, 494941/SN11000052, 492417/SN11000053, 494456/SN11000055, 494865/SN11000056, 494864/SN11000060, 495286/SN11000061, 494866/SN11000062, 494464/SN11000065, 497570/SN11000066, 488171/SN11000068, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494063/SN11000073, 494064/SN11000074, 494065/SN11000075, 497715/SN11000080, 496446/SN11000082, 496387/SN12000003, 495938/SN12000007, 495939/SN12000008, 493364/SN12000022, 493462/SN12000023, 501028/SN12000026, 500739/SN12000027, 500740/SN12000028, 502424/SN12000034, 503143/SN12000036, 503142/SN12000037, 503141/SN12000038, 503144/SN12000039, 503541/SN12000040, 500466/SN12000045, 502721/SN12000047, 505077/SN12000048, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 500468/SN12000058, 496401/SN12000059, 500467/SN12000060, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 510607/SN12000072, 512160/SN12000077, 513477/SN12000080, 513478/SN12000081, 512892/SN12000082, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 508699/SN12000088, 514462/SN12000089, 514461/SN12000090, 514104/SN12000091, 514103/SN12000092, 509062/SN12000107, 508783/SN12000108, 516891/SN12000110, 516896/SN12000111, 497572/SN12000112, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 12000166, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519506/SN13000011, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 520251/SN13000016, 520253/SN13000017, 519762/SN13000018, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520252/SN13000027, 520422/SN13000028, 520418/SN13000030, 520416/SN13000031, 520417/SN13000033, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000054, 13000055, 13000056, 13000057, 13000058, SN13000059, 13000060, SN13000061, SN13000062, SN13000063, 13000067, SN13000069, 13000070, 13000071, SN13000072, SN13000073, SN13000074, 13000075, 13000076, 13000077, 13000078, 13000079, SN13000080, SN13000082, SN13000083, SN13000084, 13000085, SN13000087, SN13000089, SN13000090, SN13000091, 13000092, 13000093, 13000094, SN13000099, SN13000100, SN13000101, SN13000102, SN13000103, SN13000104, SN13000106, SN13000107, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000139, 13000140, 13000141, 13000143, 13000144, 13000145, SN13000146, SN13000147, SN13000148, SN13000149, SN13000153, SN13000154, SN13000157, SN7369686, SN13000159, SN13000160, SN13000163, SN13000164, SN13000165, 13000167, 13000168, 13000169, SN13000170, SN13000174, SN13000176, SN13000177, SN13000179, SN13000180, SN13000181, SN13000182, SN13000183, SN13000185, 13000196, 13000199, 13000200, 13000201, 13000202, 13000203, 13000204, 13000205, SN13000206, 14000004, 14000005, 14000006, 14000008, 14000009, 14000010, 14000011, 14000013, 14000014, 14000015, 14000016, 14000017, 14000019, 14000022, 14000024, 14000026, 14000028, 14000029, 14000031, 14000032, 14000033, 14000034, 14000037, 14000038, 14000041, 14000043, 14000046, 14000047, 14000048, 14000049, 14000050, 14000051, 14000052, SN14000061, 14000069, SN14000072, 14000075, 14000077, 14000078, 14000079, 14000080, 14000081, 14000082, 14000084, 14000086, 14000087, 14000088, 14000089, SN14000096, SN14000097, SN14000098, SN14000099, SN14000100, 14000092, 14000083, 14000085, 14000103, 14000106, 14000083, 14000109, 14000112, 14000116, 14000119, 14000118, 14000120, 14000121, 14000122, 14000124, SN14000128, 14000127, 14000126, SN14000130, 14000134, 14000135, 14000138, 14000139, SN15000002, 14100044, 14100045, 14100053, 14100054, 14100085, 14100086, 14100087, 14100088, 14100090, 14100094, 14100095, 14100097, 14100101, 14100104, 14100105, 14100109, 14100111, 14100117, 14100126, 14100127, 14100128, SN14100046, 15100019, 15100023, SN14100047, SN14100055, SN14100071, SN14100072, SN14100073, SN14100074, SN14100075, 15100028, 15100034, 15100035, 15100036, 15100039, 15100040, 15100041, 15100042, 15100047, 15100048, 15100050, 15100071, 15100084, 15100087, 15100088, 15100089, 15100091, 15100092, 15100093, 15100094, 15100095, 15100097, 15100098, 15100101, 15100103, 15100104, SN15100020, SN15100009, SN15100016, SN15100010, SN15100011, SN15100013 and SN15100018.

Distribution pattern: Nationwide Distribution including 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.