Class 2 Device Recall IF 8000

• Date Initiated by Firm: January 25, 2009
• Date Posted: June 26, 2014
• Recall Status: Terminated on July 02, 2015
• Recall Number: Z-1874-2014
• Recall Event ID: 68447
• 510(K)Number: K991241
• Product Classification: Stimulator, muscle, powered - Product Code IPF
• Product: IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. ; ; Designed for use in physical therapy, rehabilitation, and pain relief applications.
• Code Information: Serial No: 2483901,2484006,2484014,2484036,2484007,2484018,2484048,2484090,2484041,2483985,2484079,2484077,2483964,2789203,2484071,2484138,2484109,2484070,2483950,2484161,2483965,2484172,2484004,2484164,2484183,2484196,2484115,2484343,2484228,2484267,2484284,2484193,2484336,2484272,2484238,2484409,2483929,2484441,2484399,2484318,2484478,2484422,2484491,2484402,2484415,2484425,2484204,2484300,2484458,2484528,2484567,2484464,2484557,2484519,2484593,2484602,2484645,2484246,2484608,2484714,2484541,2484539,2484571,2484564,2484373,2484494,2484507,2484420,2484393,2484219,2484582,2484605,2484307,2484268,2484626,2484396,2484681,2484659,2484610,2484720,2484653,2484662,2484727,2484656,2484531,2780167,2783057,2784884,2484770,2484798,2484879,2784905,2784918,2784908,2784939,2784974,2784980,2784901,2784919,2784935,2785070,2784969,2784971,2784943,2784944,2785155,2785127,2785170,2785165,2785200,2484869,2785103,2785205,2483935,2484442,2785102,2785107,2785323,2785352,2785163,2484778,2785062,2785156,2785176,2785213,2785236,2785243,2785256,2785332,2785438,2784890,2785034,2785039,2785110,2785353,2785427,2785435,2484628,2785263,2785282,2785291,2785476,2785418,2785121,2785321,2785429,2785470,2785024,2785030,2785214,2785274,2785369,2785371,2785503,2785661,2785264,2785303,2785500,2787841,2785174,2785484,2785488,2785564,2785490,2785524,2785535,2785556,2484838,2785004,2785232,2785474,2785610,2785148,2785152,2785308,2785608,2484733,2484821,2484862,2785480,2785414,2785645,2785479,2785673,2785179,2785680,2785022,2785252,2785433,2785586,2785594,2785687,2785689,2484365,2785130,2785322,2785570,2785580,2785685,2785706,2785548,2785450,2785829,2785830,2785079,2785341,2785572,2785759,2785762,2785765,2785776,2483944,2484570,2785775,2785822,2484369,2785378,2785485,2785798,2785656,2785915,2785858,2484866,2785113,2785234,2785365,2785886,2785986,2784904,2785571,2785871,2484800,2785944,2785951,2786201,2484663,2484741,2785658,2784997,2785150,2785801,2785930,2785957,2785972,2785988,2785261,2785933,2785994,2786001,2786009,2786014,2785129,2785217,2785233,2785885,2786012,2786023,2786036,2786045,2785428,2785592,2785468,2483932,2785462,2785551,2785705,2785874,2785941,2786064,2786083,2785668,2786019,2786022,2785017,2785502,2785965,2786873,2484107,2785196,2786000,2786002,2786087,2786104,2786109,2786142,2785439,2785466,2785764,2785854,2786144,2786220,2786122,2786140,2786141,2786231,2786081,2786114,2786218,2786362,2785998,2786137,2786172,2786212,2786219,2786300,2484119,2784902,2786170,2786229,2786331,2786372,2786385,2785566,2785934,2786162,2786382,2786276,2786306,2786336,2786422,2785749,2786241,2785360,2786228,2786278,2786299,2786390,2786404,2786460,2786513,2786514,2784993,2785746,2786307,2786399,2786401,2786428,2786435,2786448,2786455,2786466,2786503,2786664,2786668,2785224,2786319,2786465,2786468,2786471,2786523,2786578,2786598,2786356,2785242,2786167,2786440,2786467,2786591,2786662,2786663,2785362,2786065,2786163,2786332,2786411,2786464,2786595,2786745,2786842,2786328,2786345,2786444,2786491,2786702,2786731,2786761,2786313,2786445,2786522,2786571,2786627,2786809,2786853,2786388,2786594,2786625,2786634,2786767,2484765,2484578,2786103,2786703,2786706,2786784,2786798,2786808,2786866,2786189,2786249,2786412,2786819,2786884,2786985,2787024,2787079,2787101,2787121,2787380,2484175,2786754,2786829,2786831,2786851,2786896,2786953,2787027,2787066,2787115,2787119,2785803,2786776,2786834,2786881,2786917,2787033,2787107,2787109,2787181,2787237,2785647,2786532,2786592,2787090,2786419,2786025,2786870,2786907,2786909,2786937,2787026,2786861,2786920,2787015,2787022,2787173,2787397,2785821,2786515,2786983,2787012,2787057,2787065,2787108,2787133,2787141,2787206,2787218,2787392,2786237,2786410,2786769,2787136,2787189,2787222,2787340,2787368,2785137,2786028,2786584,2786940,2787067,2787261,2786962,2786972,2787046,2787167,2787180,2787287,2787329,2787330,2484389,2785862,2786964,2787369,2484310,2784906,2787070,2787220,2787367,2787393,2787412,2786942,2786991,2787008,2787238,2787365,2785630,2786827,2787257,2787396,2787408,2785865,2786320,2786350,2786885,2786893,2787444,2484777,2785001,2786322,2787362,2787372,2787394,2787401,2787430,2787449,2787482,2787494,2787498,2787499,2787548,2787566,2483992,2785276,2786528,2786818,2786852,2787161,2787226,2787425,2787442,2787450,2787468,2787549,2787560,2787561,2787563,2785955,2787216,2787338,2787432,2787462,2787568,2787579,2787586,2787682,2786871,2787285,2787403,2787418,2787623,2787687,2785713,2786342,2786956,2787030,2787286,2787327,2787370,2787373,2787382,2787511,2787531,2787590,2787660,2787714,2787715,2787768,2787829,2787840,2786254,2786655,2786681,2787331,2787440,2787472,2787737,2787777,2787797,2787827,2787783,2787806,2787812,2786316,2787739,2785457,2786632,2787145,2787254,2787696,2787758,2785139,2786384,2786497,2786501,2786796,2786830,2787239,2787288,2787491,2787795,2787888,2484842,2787038,2787312,2787512,2787526,2787710,2787722,2787728,2787772,2787842,2787860,2787887,2787889,2787908,2784984,2786969,2787159,2787537,2787591,2787723,2787837,2787838,2787906,2787923,2788036,2785890,2786060,2786495,2786533,2787801,2787910,2787968,2788005,2788076,2788090,2484850,2787283,2787564,2787598,2787677,2787683,2787927,2788062,2788065,2788081,2484142,2786981,2787149,2787355,2787522,2787554,2787703,2787726,2787866,2785297,2786030,2787661,2787940,2788205,2788248,2788351,2484563,2785295,2785649,2786590,2787652,2787733,2788042,2788197,2484550,2787955,2788022,2788108,2788257,2788269,2788397,2788403,2787052,2788061,2788246,2788283,2788286,2788309,2788395,2786797,2787137,2787555,2788101,2785260,2787778,2788110,2788224,2788236,2788271,2788363,2788385,2788396,2788509,2788533,2787225,2787788,2788238,2788346,2788386,2788389,2788433,2788341,2788364,2788437,2788270,2788427,2785045,2785212,2785314,2787423,2787970,2788239,2788290,2788313,2788423,2788426,2788745,2788835,2785069,2786452,2787705,2787731,2787941,2788043,2788421,2788560,2788631,2784977,2786486,2787360,2787542,2787735,2787872,2788109,2788177,2788350,2788604,2788607,2788696,2788898,2789311,2784912,2788016,2788122,2788178,2788414,2788438,2788469,2788496,2788683,2788684,2788841,2788884,2788918,2786487,2787518,2788161,2788183,278834,2788405,2788593,2788359,2788186,2788616,2787028,2787441,2787861,2787870,2788432,2788566,2788594,2788619,2788722,2788836,2787523,2787984,2788040,2788170,2788221,2788476,2788610,2788686,2788688,2788691,2788828,2788921,2789024,2789032,2789034,2788783,2789026,2788822,2789057,2789347,2786794,2787125,2788115,2788711,2789051,2789058,2786512,2787624,2788488,2788569,2788574,2788747,2788762,2788973,2789076,2789208,2786700,2788731,2789082,2789084,2789092,2789120,2789128,2789164,2789181,2789189,2789019,2787957,2787979,2788977,2789106,2789126,2788885,2789080,2789081,2789253,2789269,2789366,2785140,2785512,2787095,2788217,2788449,2788741,2788840,2789013,2785813,2788457,2788855,2789135,2789239,2789289,2789472,2789547,2788526,2788720,2788770,2788927,2788929,2788949,2788962,2789054,2790376,2789240,2789843,2785996,2788675,2789316,2789318,2789548,2789865,2789871,2786541,2787636,2788375,2789254,2789393,2789399,2789546,2789714,2786817,2788212,2788794,2789073,2789154,2789234,2789247,2789423,2789447,2789536,2789544,2789881,2785005,2786692,2789390,2789404,2789454,2789595,2789965,2789353,2789376,2789493,2789533,2789653,2789675,2789855,2789861,2788937,2789844,2789348,2789365,2789530,2789583,2789622,2789663,2789665,2789705,2789841,2789862,2788074,2788084,2788559,2789275,2789435,2789438,2788051,2788151,2789097,2789441,2789539,2789661,2789670,2789679,2789703,2789718,2789987,2789988,2784978,2785826,2786958,2788340,2788883,2789335,2789364,2789492,2789633,2789646,2789678,2789929,2788494,2789408,2789433,2789637,2789689,2789699,2789878,2789928,2788868,2789706,2786859,2787354,2788072,2788887,2788892,2788910,2789527,2789528,2789534,2789628,2789630,2789631,2789815,2789820,2789992,2790008,2788147,2788506,2789606,2789786,2789791,2789850,2789953,2484700,2785444,2786095,2786351,2786403,2788640,2789248,2789357,2789463,2789650,2789656,2789753,2789811,2790033,2790043,2790048,2790057,2789250,2789322,2789374,2789379,2789430,2789521,2789526,2789560,2789707,2789798,2789930,2789959,2789977,2790060,2790072,2790109,2785537,2787460,2789262,2789758,2789828,2789924,2790097,2790669,2789305,2484853,2785329,2787755,2789523,2789848,2790049,2790096,2484306,2787124,2788137,2788463,2788495,2788548,2789265,2789767,2788280,2789733,2789781,2789927,2790016,2787814,2788905,2789449,2789765,2789919,2790001,2790066,2790160,2790166,2790333,2790334,2790337,2785367,2788371,2788576,2789490,2790195,2790011,2790019,2787345,2788715,2789458,2789793,2790271,2790279,2790361,2790562,2788602,2788707,2789360,2789829,2790241,2790285,2790484,2790491,2790519,2790527,2785774,2786555,2789580,2789736,2789759,2790253,2785780,2786180,2788020,2789559,2790270,2790281,2790332,2484779,2786082,2788953,2789616,2789819,2790111,2790135,2790142,2790299,2790385,2790516,2790524,2790540,2790556,2484408,2790071,2786072,2786961,2790175,2790202,2790531,2785434,2788704,2790267,2790499,2483906,2785993,2788291,2788553,2789091,2789498,2789505,2789888,2790345,2484461,2484768,2790323,2790368,2790370,2790500,2790532,2790659,2790749,2790771,2788415,2789917,2790155,2790295,2790474,2790476,2790512,2790551,2790561,2790593,2790651,2790747,2790829,2790891,2790024,2790261,2790472,2790666,2790758,2790773,2790775,2785522,2786968,2787762,2787877,2790288,2790407,2790570,2787868,2788760,2790055,2790126,2790194,2790245,2790650,2790699,2790721,2790791,2790825,2790935,2786116,2788663,2788699,2790006,2790408,2790449,2790455,2790804,2790987,2788125,2789568,2789779,2790418,2790446,2790625,2790639,2790643,2787274,2787622,2788521,2790399,2790647,2790680,2790882,2790887,2790991,2791056,2789474,2790762,2790765,2788788,2785517,2787822,2788032,2790182,2790214,2790292,2790485,2790618,2790628,2790875,2790964,2483970,2784992,2790655,2790692,2790738,2790789,2790924,2790929,2786509,2788153,2790177,2790623,2790999,2791003,2791183,2791188,2791190,2791328,2787655,2787657,2790025,2790567,2790838,2791136,2787359,2790645,2790993,2791048,2791271,2791289,2790878,2790949,2791133,2791265,2791284,2791521,2785983,2786016,2790589,2790889,2790895,2791147,2791194,2786696,2788617,2790377,2790833,2790965,2791117,2791288,2484796,2785618,2790837,2791134,2791146,2791228,2791270,2791292,2791333,2791359,2791363,2791365,2791562,2791575,2791627,2484865,2789727,2789991,2790763,2790899,2791022,2791029,2791050,2791285,2791334,2791430,2790411,2790445,2791498,2791502,2790967,2791222,2791495,2484208,2785784,2787951,2791004,2791025,2791479,2791500,2785208,2787635,2788759,2790378,2790860,2791044,2791199,2791349,2791549,2791588,2484361,2790064,2790572,2791027,2791336,2791342,2791453,2791576,2791667,2788671,2790065,2790835,2791077,2791404,2791800,2787458,2788208,2788240,2789746,2790213,2790335,2790832,2790981,2791366,2791451,2791694,2790939,2790945,2791692,2791710,2791711,2791716,2791727,2784982,2790216,2791166,2788365,2790379,2791409,2791508,2791538,2791661,28813066,2791282,2791286,2791425,2791511,2791513,2791636,2791765,2791811,2791876,28812529,2787604,2790903,2791542,2791794,2791808,2791818,28810116,28813096,2484397,2790282,2790517,2790901,2790962,2791107,2791433,2791545,2791742,2791776,2791877,2791880,2790429,2788026,2788211,2790035,2791700,2791790,2791883,28812516,2484835,2787062,2787342,2790460,2790648,2790671,2790689,2791606,2791697,2791872,28813050,28813109,28813110,28813114,2787754,2790790,2790849,2791157,2791554,2791745,2791867,2791868,28813070,28813076,28813079,28813094,2786327,2788901,2790451,2791633,2791647,2791706,2791803,2791828,2791862,28813202,28813235,2786323,2789442,2790390,2790674,2790730,2785513,2791251,2791254,2791506,2791754,28812524,28813067,28813100,28813200,28813201,28813390,2789508,2789742,2790042,2791358,28813047, and 28813400.
• Recalling Firm/ Manufacturer: Zynex Medical, Inc.; 9990 Park Meadows Dr; Lone Tree CO 80124-6739
• For Additional Information Contact: Thomas Sandgaard; 303-703-4906
• Manufacturer Reason for Recall: Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
• FDA Determined Cause: Component design/selection
• Action: Consignees were notified via letter on 6/25/2009. The letter identified the reason for the recall, and stated that customers could contact customer service at 1-866-940-7030 if they encountered any difficulties with the affected product. Otherwise, they could continue using the product as they have in the past.
• Quantity in Commerce: 1,461
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IPF and Original Applicant = DAN MED, INC.