Recall Z-1874-2014 ยท IPF Stimulator, Muscle, Powered
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.
| Date | Jun 26, 2014 (initiated Jan 25, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991241 | IF8000 Dan Med, Inc., Nov 2, 1999 |