Recall Z-1874-2014
Zynex Medical, Inc. · initiated January 25, 2009
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial No: 2483901,2484006,2484014,2484036,2484007,2484018,2484048,2484090,2484041,2483985,2484079,2484077,2483964,2789203,2484071,2484138,2484109,2484070,2483950,2484161,2483965,2484172,2484004,2484164,2484183,2484196,2484115,2484343,2484228,2484267,2484284,2484193,2484336,2484272,2484238,2484409,2483929,2484441,2484399,2484318,2484478,2484422,2484491,2484402,2484415,2484425,2484204,2484300,2484458,2484528,2484567,2484464,2484557,2484519,2484593,2484602,2484645,2484246,2484608,2484714,2484541,2484539,2484571,2484564,2484373,2484494,2484507,2484420,2484393,2484219,2484582,2484605,2484307,2484268,2484626,2484396,2484681,2484659,2484610,2484720,2484653,2484662,2484727,2484656,2484531,2780167,2783057,2784884,2484770,2484798,2484879,2784905,2784918,2784908,2784939,2784974,2784980,2784901,2784919,2784935,2785070,2784969,2784971,2784943,2784944,2785155,2785127,2785170,2785165,2785200,2484869,2785103,2785205,2483935,2484442,2785102,2785107,2785323,2785352,2785163,2484778,2785062,2785156,2785176,2785213,2785236,2785243,2785256,2785332,2785438,2784890,2785034,2785039,2785110,2785353,2785427,2785435,2484628,2785263,2785282,2785291,2785476,2785418,2785121,2785321,2785429,2785470,2785024,2785…
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 taken
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.
Details
- Recall number
- Z-1874-2014
- Initiated
- January 25, 2009
- Posted by FDA
- June 26, 2014
- Terminated
- July 2, 2015
- Product code
- IPF – Stimulator, Muscle, Powered
- Quantity
- 1,461
- Distribution
- Nationwide Distribution
- Recalling firm
- Zynex Medical, Inc., Lone Tree, CO