The Recall Desk
HighFDA (Devices)·Z-0455-2024·Announced 2023-12-13

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
Category
Medical Device — Light Therapy Equipment
Hazard
Affected units
26

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.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Thor Photomedicine Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Thor Photomedicine Ltd

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Same hazard · component failure

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