THOR Photomedicine Ltd: Device Recall
Recall #Z-2416-2025 · 07/24/2025
Recall Details
- Recall Number
- Z-2416-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- THOR Photomedicine Ltd
- Status
- Ongoing
- Date Initiated
- 07/24/2025
- Location
- Amersham, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units (66 US, 14 OUS)
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.
Product Description
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 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: No
Distribution Pattern
Worldwide distribution: US (nationwide): 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 OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.
Other Recalls by THOR Photomedicine Ltd
- Class II: Risk 07/24/2025
- Class II: Risk 07/24/2025
- Class II: Risk 07/24/2025