THOR NovoTHOR Heating Device Canopy May Become Difficult to Lift Due to Weld Failure
The THOR NovoTHOR Gen 3.0 Reg PRX therapeutic heating device may have a faulty welded nut that can shear off. This causes the gas strut to detach, making the canopy difficult to lift and potentially affecting device use.
What this means for you
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 a Class II FDA medical device recall involving a mechanical defect (welded nut failure) with no reported injuries or illnesses. The primary effect is difficulty in device operability rather than an acute safety hazard.
Plain-English summary
The THOR NovoTHOR Gen 3.0 Reg PRX is a therapeutic heating device designed to emit visible and infrared spectrum energy to provide topical heating. It is intended to elevate tissue temperature for temporary relief of minor muscle and joint pain, arthritis pain, and muscle spasm. Two units have been identified with a potential mechanical defect.
THOR Photomedicine Ltd has issued a recall because the device contains a welded nut that may fail and shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift and potentially affecting proper device operation.
The affected products are Model/Catalog Number S2186 with serial numbers 4005 and 4062. One unit was distributed in the United States across multiple states, and one unit was distributed internationally to Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, and Spain.
Consumers who own affected units should discontinue use and contact THOR Photomedicine Ltd for instructions regarding inspection or replacement.
The recalled product
- Product
- Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
- Manufacturer
- THOR Photomedicine Ltd
- Hazard
- weld-failure
- mechanical-defect
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 (3)
- Model/Catalog Number: S2186
- UDI-DI: Serial numbers: 4005
- 4062
Distribution
Distributed nationwide across the United States.
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