Z-1874-2014Class II

IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode...

Name: Z-1874-2014 IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode...
Creator: Zynex Medical, Inc.
Published: 2009-01-25
License: https://open.fda.gov/license/

Altivera Medical, Inc. / initiated 2009-01-25 / Terminated / root cause: design

FDA source

Zynex Medical, Inc. began a recall of IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy... on 2009-01-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1874-2014
Classification: Class II
Status: Terminated
Initiated: 2009-01-25
Posted: 2014-06-26
Terminated: 2015-07-02
Recalling firm: Altivera 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.
Product code: IPF Stimulator, Muscle, Powered
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.
Root cause tag: design
FDA 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 in commerce: 1,461
Distribution: Nationwide Distribution
Product codes and lots: 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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and 28813400.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1874-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1874-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-26

Product code IPF

K991241Class IIIf8000Dan Med, Inc. / cleared 1999-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)