Class 2 Device Recall THOR

• Date Initiated by Firm: July 24, 2025
• Date Posted: August 22, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2418-2025
• Recall Event ID: 97297
• Product Classification: Lamp, infrared, therapeutic heating - Product Code ILY
• 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
• Code Information: Model/Catalog Number: S2189; UDI-DI: 05060494130480; Only one device of this type is in scope. Serial number: 4068
• Recalling Firm/ Manufacturer: THOR Photomedicine Ltd; 2 Anglo Office Park; Units 1 &; 67 White Lion Road; Amersham United Kingdom
• For Additional Information Contact: Ian Clinch; +44-149-4797100
• Manufacturer 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.
• FDA Determined 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 the device was sold and reply to this email with the contact details of the new owner. Other Actions for Owners: Should you continue to have users/patients use the NovoTHOR, then be aware it may potentially cause harm should the failure occur whilst they are lifting or lowering the canopy. " Ensure you warn all users of the potential risk " Ensure someone is present to lift and lower the canopy " Ensure the canopy is lifted and lowered gently and slowly " Ensure someone is present in the room or immediately outside the room during use. THOR Contact Information: Call +44 (0)1494 797 100, Monday through Friday, 5:00 AM to 2:00 PM, Eastern Time or via thorlaser.com/contact.htm.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.