NovoTHOR XL devices recalled over failed welded nut detaching gas strut
NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.
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 XL, model and catalog number S2190, UDI-DI 05060494130510, is being recalled. Affected units are identified by serial numbers including 4006, 4007, 4008, 4011, 4018, 4023 and 4025, with the full list in the recall notice. The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and infrared spectrum to provide topical heating. The recall covers 55 units, of which 41 are in the United States and 14 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 XL Model/Catalog Number: S2190 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 tissue temperature
- 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 (20)
- Model/Catalog Number: S2190
- UDI-DI: 05060494130510
- Serial Numbers: 4006
- 4007
- 4008
- 4011
- 4018
- 4023
- 4025
- 4027
- 4031
- 4032
- 4034
- 4039
- 4041
- 4051
- 4052
- 4053
- 4056
- 4057
Distribution
Distributed nationwide across the United States.
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