Light therapy devices recalled over welded nut that may shear off
Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.
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: Rubric level 2 covers precautionary recalls; the notice states the canopy becomes difficult to lift, without describing any injury or further consequence.
Plain-English summary
The THOR NovoTHOR Gen 3.0 Reg PRX, model and catalog number S2186, is being recalled for serial numbers 4005 and 4062. The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and infrared spectrum to provide topical heating. The recall covers 2 units, one in the United States and one outside it.
The recall was issued because of the potential for a failed welded nut to 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. The FDA classified the action as Class II.
Owners of affected units should follow the manufacturer's instructions for inspection and repair.
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
- Category
- Medical Device — Light Therapy
- Hazard
- component-failure
- gas-strut
- class-ii
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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