Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: structural-failure
canopy-detachment
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 →

Same manufacturer · Thor Photomedicine Ltd

See all →

Moderate
Light therapy devices recalled over welded nut that may shear off
FDA (Devices) · 2025-09-03
Moderate
NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy
FDA (Devices) · 2025-09-03
Moderate
NovoTHOR light therapy devices recalled over welded nut that may shear
FDA (Devices) · 2025-09-03
Moderate
NovoTHOR XL devices recalled over failed welded nut detaching gas strut
FDA (Devices) · 2025-09-03
High
NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail
FDA (Devices) · 2024-02-07

Same hazard · structural failure