Zynex Medical, Inc.: IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.

Recall number

Z-1874-2014

Recalling firm

Zynex Medical, Inc.

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.

Status

Terminated

Initiated

2009-01-25

Posted

2014-06-26

Terminated

2015-07-02

Reason

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.

Root 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

1,461

Distribution

Nationwide Distribution

Lot, serial or model codes

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,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791289,2790878,2790949,2791133,2791265,2791284,2791521,2785983,2786016,2790589,2790889,2790895,2791147,2791194,2786696,2788617,2790377,2790833,2790965,2791117,2791288,2484796,2785618,2790837,2791134,2791146,2791228,2791270,2791292,2791333,2791359,2791363,2791365,2791562,2791575,2791627,2484865,2789727,2789991,2790763,2790899,2791022,2791029,2791050,2791285,2791334,2791430,2790411,2790445,2791498,2791502,2790967,2791222,2791495,2484208,2785784,2787951,2791004,2791025,2791479,2791500,2785208,2787635,2788759,2790378,2790860,2791044,2791199,2791349,2791549,2791588,2484361,2790064,2790572,2791027,2791336,2791342,2791453,2791576,2791667,2788671,2790065,2790835,2791077,2791404,2791800,2787458,2788208,2788240,2789746,2790213,2790335,2790832,2790981,2791366,2791451,2791694,2790939,2790945,2791692,2791710,2791711,2791716,2791727,2784982,2790216,2791166,2788365,2790379,2791409,2791508,2791538,2791661,28813066,2791282,2791286,2791425,2791511,2791513,2791636,2791765,2791811,2791876,28812529,2787604,2790903,2791542,2791794,2791808,2791818,28810116,28813096,2484397,2790282,2790517,2790901,2790962,2791107,2791433,2791545,2791742,2791776,2791877,2791880,2790429,2788026,2788211,2790035,2791700,2791790,2791883,28812516,2484835,2787062,2787342,2790460,2790648,2790671,2790689,2791606,2791697,2791872,28813050,28813109,28813110,28813114,2787754,2790790,2790849,2791157,2791554,2791745,2791867,2791868,28813070,28813076,28813079,28813094,2786327,2788901,2790451,2791633,2791647,2791706,2791803,2791828,2791862,28813202,28813235,2786323,2789442,2790390,2790674,2790730,2785513,2791251,2791254,2791506,2791754,28812524,28813067,28813100,28813200,28813201,28813390,2789508,2789742,2790042,2791358,28813047, and 28813400.

510(k) numbers

["K991241"]

PMA numbers

not on file

Product code

IPF

Firm FEI

3000214920

Firm city

Lone Tree

Firm state

CO

Firm country

not on file

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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