The Recall Desk
HighFDA (Devices)·Z-0453-2024·Announced 2023-12-13

NovoTHOR Gen 2.0 Light Therapy Bed Canopy Detachment Due to Ball Stud Failure

Thor Photomedicine is recalling 19 NovoTHOR Gen 2.0 red light therapy beds due to ball stud component failures that can cause canopy detachment or difficulty in lifting. The beds were distributed worldwide.

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: The ball stud component failure is a confirmed structural defect that can cause canopy detachment. This constitutes a risk-of-harm product where no injuries have been reported in the source, placing it in the High severity category. The confirmed nature of the hazard and its potential for injury warrant this classification despite the limited number of affected units.

Plain-English summary

Thor Photomedicine Ltd is recalling the NovoTHOR Gen 2.0 whole body red light therapy bed (model S1176) due to failures of ball stud components in the gas strut mechanism. Nineteen units with specific serial numbers have been identified as affected.

The failure of these ball stud components causes the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

The affected units have been distributed worldwide, including to 22 US states and internationally to Australia, Canada, the Netherlands, New Zealand, Singapore, and the United Kingdom.

Users with affected units should contact Thor Photomedicine Ltd regarding the recall. Affected serial numbers can be verified through FDA recall notice Z-0453-2024.

The recalled product

Product
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Manufacturer
Thor Photomedicine Ltd
Category
Medical Device — Light Therapy Equipment
Hazard
Affected units
19

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: 2003
  • 2004
  • 2005
  • 2006
  • 2007
  • 2009
  • 2010
  • 2011
  • 2017
  • 2018
  • 2015
  • 2020
  • 2019
  • 2001
  • 2021
  • 2028
  • 2033
  • 2036
  • 2030
  • 2029.

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 · structural failure

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