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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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.
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