NovoTHOR Gen 2.5 Therapy Bed Recalled for Ball Stud Failure
Thor Photomedicine's NovoTHOR Gen 2.5 therapy beds are being recalled due to failure of ball stud components in the gas strut, which can detach from the canopy. This affects 26 units distributed across the US and internationally.
What this means for you
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: FDA Class II medical device recall involving mechanical component failure that affects device operation. While no injuries have been reported, the gas strut detachment constitutes a risk-of-harm defect. This meets the criteria for Score 3 (High): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Thor Photomedicine Ltd is recalling 26 units of the NovoTHOR Gen 2.5 Regular whole body red light therapy bed (model S2183). The product has a mechanical defect in which ball stud components in the gas strut can fail, causing the strut to detach from the canopy on one side.
When the gas strut detaches, the canopy becomes difficult to lift. This affects the device's normal operation and functionality.
The recalled devices have been distributed nationwide across the United States and internationally to Australia, Canada, Netherlands, New Zealand, Singapore, and the United Kingdom. The FDA has identified specific affected serial numbers for this recall.
The recalled product
- Product
- NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
- Manufacturer
- Thor Photomedicine Ltd
- Hazard
- component-failure
- gas-strut-detachment
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 numbers: 2002
- 2050
- 2051
- 2052
- 2053
- 2054
- 2055
- 2056
- 2057
- 2059
- 2060
- 2061
- 2062
- 2064
- 2065
- 2066
- 2075
- 2076
- 2077
- 2078
Distribution
Distributed nationwide across the United States.
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