Phototherapy Device Canopy May Detach Due to Weld Failure
THOR NovoTHOR phototherapy devices (Model S2188) may have a failed welded nut causing the canopy gas strut to detach, making the canopy difficult to lift. Eighty units have been recalled.
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: This is an FDA Class II medical device recall involving a structural defect—a failed welded nut that causes a gas strut to detach. Although no injuries have been reported, the defect creates a risk of harm through canopy instability and difficulty in safe operation, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
THOR Photomedicine Ltd is recalling the NovoTHOR and NovoTHOR XL phototherapy devices (Model S2188) used for topical heating to provide temporary relief of muscle and joint pain.
A welded nut that secures the gas strut supporting the canopy may fail and shear off. When this occurs, the gas strut becomes detached from one side of the canopy, making the canopy difficult to lift.
Sixty-six units were distributed in the United States across multiple states (AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV), and fourteen units were distributed internationally in Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, and Spain. The affected devices have specific serial numbers documented in the FDA recall notice.
If you own or operate one of these devices, contact THOR Photomedicine Ltd for instructions. Check your device's serial number to determine if it is included in this recall.
The recalled product
- Product
- Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
- Manufacturer
- THOR Photomedicine Ltd
- Hazard
- structural-defect
- weld-failure
- canopy-instability
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)
- Model/Catalog Number: S2188
- UDI-DI: 05060494130503
- Serial Numbers: 4004
- 4015
- 4017
- 4019
- 4021
- 4022
- 4024
- 4026
- 4028
- 4029
- 4035
- 4036
- 4037
- 4042
- 4043
- 4044
- 4046
- 4047
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03