IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed fo
FDA device recall Z-1874-2014 · posted 2014-06-26 · Terminated
Recall details
- Recalling firm
- Zynex Medical, Inc.
- 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.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IPF
- Quantity affected
- 1,461
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-01-25
- Date posted
- 2014-06-26
- Date terminated
- 2015-07-02
- Location
- Lone Tree, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IF8000 (K991241) | Dan Med, Inc. | 1999-11-02 |