Recall Z-2418-2025 ยท ILY Lamp, Infrared, Therapeutic Heating
THOR Photomedicine Ltd
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 stiffne
| Date | Aug 22, 2025 (initiated Jul 24, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On July 24, 2025, IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions by THOR: A service agent representing THOR will contact you within the next 10 weeks to schedule the fitting of the four high tensile strength steel bolts to the inside of the chassis. The process is likely to take around 3 hours and, of course, there is no fee. Required Actions for NovoTHOR Owners: 1. Please reply to this email within four days to acknowledge your receipt and understanding of this notification. 2. If you no longer own the NovoTHOR, please forward this notice to the new owner if |
| Quantity | 1 unit |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.