Recall Z-2418-2025— THOR Photomedicine Ltd
Class II · Ongoing
Class II FDA medical device recall by THOR Photomedicine Ltd, initiated 2025-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 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 for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A. Reason: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift..
- Recalling firm
- THOR Photomedicine Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-24
- Firm location
- Amersham, United Kingdom
Product description
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 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 for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A
Reason for recall
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Data sourced from openFDA. This site is unofficial and independent of the FDA.