IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
FDA Recall Z-1874-2014 · Posted 2014-06-26
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Recalling FirmZynex Medical, Inc.
Recall StatusTerminated
Product CodeIPF
Date Initiated2009-01-25
Date Terminated2015-07-02
Product Quantity1,461
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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