FDA Warning Letter After Zynex NexWave, IF8000 Recall

FDA Warning Letter After Zynex NexWave, IF8000 RecallJuly 9, 2014 — The U.S. Food and Drug Administration (FDA) has issued a warning letter to Zynex Medical, Inc. for failing to report a recall and failing to adequately document adverse event reports involving the NexWave and IF8000 chronic pain devices.

The electrotherapy pain management devices are advertised as a way to augment healing, reduce inflammation, improve blood circulation, and alleviate pain.

On June 26, the FDA published a Class II recall for the IF 8000 electrical stimulator. Unfortunately, a malfunction can result in the device not operating, overheating, and becoming hot to the touch.

Zynex notified customers about the recall in 2009 but failed to notify the FDA. According to the letter:

“Between June 25, 2009, and July 9, 2009, your firm sent approximately 2,978 recall letters to customers notifying them of the defect and requesting they contact your company. You did not notify FDA, in writing, within ten days of initiating this removal.”

When the FDA inspected the company in Lone Tree, Colorado on January 6, 2014, they observed a number of violations associated with the NexWave and the IF8000 electrical stimulators. Many of these violations involved failure to establish procedures for design

The FDA found that Zynex failed to establish procedures for reviewing complaints, which could result in failure to identify malfunctions that could lead to life-threatening injuries or death. The company also failed to document any reports or investigations associated with product complaints.

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