The Recall Desk
HighFDA (Devices)·Z-1874-2014·Announced 2014-07-02

Zynex IF 8000 Interferential Electrical Stimulation Device Recalled for Overheating

Zynex Medical is recalling 1,461 IF 8000 devices because a malfunction can cause them to stop working or overheat, posing a burn risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential burn injury from overheating) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Zynex Medical, Inc. is recalling 1,461 units of the IF 8000 Interferential Electrical Stimulation Device. These devices are designed for use in physical therapy, rehabilitation, and pain relief applications, specifically in the NMES (neuromuscular electrical stimulation) mode. The recall covers devices distributed nationwide.

The recall was initiated because a malfunction in the IF 8000 can result in the device ceasing to operate. In some instances, the device may overheat and become hot to the touch, which presents a risk of burn injury to users.

Consumers who possess one of the affected serial numbers should stop using the device immediately and contact Zynex Medical for instructions on how to proceed with the recall.

The recalled product

Product
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
Manufacturer
Zynex Medical, Inc.
Category
Medical Device — Physical Therapy Equipment
Hazard
Affected units
1,461

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial No: 2483901
  • 2484006
  • 2484014
  • 2484036
  • 2484007
  • 2484018
  • 2484048
  • 2484090
  • 2484041
  • 2483985
  • 2484079
  • 2484077
  • 2483964
  • 2789203
  • 2484071
  • 2484138
  • 2484109
  • 2484070
  • 2483950
  • 2484161

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · burn injury

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