July 9, 2014 — Zynex Medical Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA) for failing to notify the agency of a recall back in 2009 and failing to appropriately document complaints associated with the NexWave and IF8000 chronic pain devices.
The electrical stimulation devices are used in physical therapy, rehabilitation, and pain relief. They are advertised as a way to augment healing, reduce swelling, and increase blood circulation through the use of electrical currents.
The FDA published a Class II recall for the IF8000 and NexWave on June 26. Complaints describe problems in which the device stops working, overheats, and becomes too hot to touch.
Between June 25 and July 9, 2009, Zynex sent nearly 3,000 letters to customers to notify them of the defect. Zynex requested that customers contact the company. However, Zynex failed to notify the FDA of the recall within 30 days, as is required by law.
According to the FDA:
“We reviewed your firm’s response and conclude that it is not adequate. Although you have submitted the subject removal to FDA, you did not address how you will verify that there were no other corrections or removals required to be reported to FDA that have not been reported.”
The problems were documented during an inspection in January. The FDA also found serious problems with the company’s procedures for reviewing and investigating complaints, which could potentially allow dangerous malfunctions to slip through the cracks.
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