Diowave Laser System Software Update Required for Power Output Issue
Diowave 250W Laser Systems require a software update because some units operate at up to 70W maximum average power output, exceeding the FDA-cleared limit of 60W.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or adverse events. The hazard is a power output specification discrepancy that requires correction via software update, which is a voluntary precautionary action.
Plain-English summary
Technological Medical Advancements LLC is recalling Diowave Laser Systems (Model REF: Diowave 250W, UDI-DI: G180DIOWAVESTEALTHMAX0) with all software versions prior to V1.81. The systems are used for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, and stiffness associated with minor arthritis, and to temporarily increase local blood circulation.
The systems operate at a maximum average power output of 70W, which exceeds the FDA-cleared power output of 60W. This discrepancy between the actual and cleared operating parameters requires a software update to bring the devices into compliance.
Approximately 16 units have been distributed nationwide, with distribution documented in Texas, California, Michigan, Maryland, Pennsylvania, Florida, Minnesota, and the District of Columbia. Users of affected devices should contact the manufacturer for instructions on obtaining and installing the required software update to V1.81 or later.
The recalled product
- Product
- Diowave Laser System, REF: Diowave 250W
- Manufacturer
- Technological Medical Advancements LLC
- Affected units
- 16
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 (2)
- UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to
- but not including V1.81
Distribution
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