FDAFDA · Food and drugs·Recall number Z-1874-2014
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
Published July 2, 2014 · Recall initiated: January 25, 2009
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zynex Medical, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Serial No: 2483901,2484006,2484014,2484036,2484007,2484018,2484048,2484090,2484041,2483985,2484079,2484077,2483964,2789203,2484071,2484138,2484109,2484070,2483950,2484161,2483965,2484172,2484004,2484164,2484183,2484196,2484115,2484343,2484228,2484267,2484284,2484193,2484336,2484272,2484238,2484409,2483929,2484441,2484399,2484318,2484478,2484422,2484491,2484402,2484415,2484425,2484204,2484300,2484458,2484528,2484567,2484464,2484557,2484519,2484593,2484602,2484645,2484246,2484608,2484714,2484541,2484539,2484571,2484564,2484373,2484494,2484507,2484420,2484393,2484219,2484582,2484605,2484307,2484268,2484626,2484396,2484681,2484659,2484610,2484720,2484653,2484662,2484727,2484656,2484531,2780167,2783057,2784884,2484770,2484798,2484879,2784905,2784918,2784908,2784939,2784974,2784980,2784901,2784919,2784935,2785070,2784969,2784971,2784943,2784944,2785155,2785127,2785170,2785165,2785200,2484869,2785103,2785205,2483935,2484442,2785102,2785107,2785323,2785352,2785163,2484778,2785062,2785156,2785176,2785213,2785236,2785243,2785256,2785332,2785438,2784890,2785034,2785039,2785110,2785353,2785427,2785435,2484628,2785263,2785282,2785291,2785476,2785418,2785121,2785321,2785429,2785470,2785024,2785030,2785214,2785274,2785369,2785371,2785503,2785661,2785264,2785303,2785500,2787841,2785174,2785484,2785488,2785564,2785490,2785524,2785535,2785556,2484838,2785004,2785232,2785474,2785610,2785148,2785152,2785308,2785608,2484733,2484821,2484862,2785480,2785414,2785645,2785479,2785673,2785179,2785680,2785022,2785252,2785433,2785586,2785594,2785687,2785689,2484365,2785130,2785322,2785570,2785580,2785685,2785706,2785548,2785450,2785829,2785830,2785079,2785341,2785572,2785759,2785762,2785765,2785776,2483944,2484570,2785775,2785822,2484369,2785378,2785485,2785798,2785656,2785915,2785858,2484866,2785113,2785234,2785365,2785886,2785986,2784904,2785571,2785871,2484800,2785944,2785951,2786201,2484663,2484741,2785658,2784997,2785150,2785801,2785930,2785957,2785972,2785988,2785261,2785933,2785994,2786001,2786009,2786014,2785129,2785217,2785233,2785885,2786012,2786023,2786036,2786045,2785428,2785592,2785468,2483932,2785462,2785551,2785705,2785874,2785941,2786064,2786083,2785668,2786019,2786022,2785017,2785502,2785965,2786873,2484107,2785196,2786000,2786002,2786087,2786104,2786109,2786142,2785439,2785466,2785764,2785854,2786144,2786220,2786122,2786140,2786141,2786231,2786081,2786114,2786218,2786362,2785998,2786137,2786172,2786212,2786219,2786300,2484119,2784902,2786170,2786229,2786331,2786372,2786385,2785566,2785934,2786162,2786382,2786276,2786306,2786336,2786422,2785749,2786241,2785360,2786228,2786278,2786299,2786390,2786404,2786460,2786513,2786514,2784993,2785746,2786307,2786399,2786401,2786428,2786435,2786448,2786455,2786466,2786503,2786664,2786668,2785224,2786319,2786465,2786468,2786471,2786523,2786578,2786598,2786356,2785242,2786167,2786440,2786467,2786591,2786662,2786663,2785362,2786065,2786163,2786332,2786411,2786464,2786595,2786745,2786842,2786328,2786345,2786444,2786491,2786702,2786731,2786761,2786313,2786445,2786522,2786571,2786627,2786809,2786853,2786388,2786594,2786625,2786634,2786767,2484765,2484578,2786103,2786703,2786706,2786784,2786798,2786808,2786866,2786189,2786249,2786412,2786819,2786884,2786985,2787024,2787079,2787101,2787121,2787380,2484175,2786754,2786829,2786831,2786851,2786896,2786953,2787027,2787066,2787115,2787119,2785803,2786776,2786834,2786881,2786917,2787033,2787107,2787109,2787181,2787237,2785647,2786532,2786592,2787090,2786419,2786025,2786870,2786907,2786909,2786937,2787026,2786861,2786920,2787015,2787022,2787173,2787397,2785821,2786515,2786983,2787012,2787057,2787065,2787108,2787133,2787141,2787206,2787218,2787392,2786237,2786410,2786769,2787136,2787189,2787222,2787340,2787368,2785137,2786028,2786584,2786940,2787067,2787261,2786962,2786972,2787046,2787167,2787180,2787287,2787329,2787330,2484389,2785862,2786964,2787369,2484310,2784906,2787070,2787220,2787367,2787393,2787412,2786942,2786991,2787008,2787238,2787365,2785630,2786827,27872
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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