The Recall Desk
HighFDA (Devices)·Z-0456-2024·Announced 2023-12-13

NovoTHOR Gen 2.5 XL Red Light Therapy Bed Canopy Gas Strut Detachment Recall

Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.

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 without reported injuries or hospitalizations. The hazard presents a mechanical risk-of-harm (gas strut detachment and canopy dysfunction) but no illnesses or injuries have been reported, meeting the rubric criterion for score 3.

Plain-English summary

Thor Photomedicine Ltd is recalling 26 NovoTHOR Gen 2.5 XL whole body red light therapy beds (model S2184) due to failure of ball stud components in the canopy assembly. This failure can cause the gas strut on one side to detach, making the canopy difficult to lift.

The affected units were distributed worldwide, including to locations throughout the United States (Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Oregon, Texas, Utah, Virginia, and West Virginia) and internationally to Australia, Canada, Netherlands, New Zealand, Singapore, and the United Kingdom. The recall affects units with the following serial numbers: 3025, 3026, 3027, 3030, 3031, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3042, 3043, 3044, 3045, 3047, 3050, 3051, and 3053.

The recalled product

Product
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
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: 3025
  • 3026
  • 3027
  • 3030
  • 3031
  • 3034
  • 3035
  • 3036
  • 3037
  • 3038
  • 3039
  • 3040
  • 3042
  • 3043
  • 3044
  • 3045
  • 3047
  • 3050
  • 3051
  • 3053.

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

See all →