FDA · Medical device recall

Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188… and 3 more products

Sept. 3, 2025 Class II

Date: Sept. 3, 2025
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: THOR Photomedicine Ltd
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.
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.

4 products in this recall

Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A 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 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
Quantity: 80 units (66 US, 14 OUS)
Codes and lots: 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, 4049, 4054, 4055, 4059, 4066, 4071, 4072, 4073, 4074, 4076, 4077, 4078, 4079, 4082, 4083, 4084, 4085, 4086, 4087, 4088, 4090, 4091, 4094, 4095, 4097, 4099, 4101, 4105, 4106, 4111, 4112, 4114, 4116, 4117, 4121, 4123, 4124, 4125, 4126, 4130, 4140, 4141, 4143, 4144, 4151, 4153, 4157, 4158, 4009, 4020, 4103, 4107, 4109, 4110, 4113, 4120, 4122, 4127, 4133, 4134, 4138, 4139;
Recall started: July 24, 2025
Device type: Lamp, Infrared, Therapeutic Heating
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2416-2025

Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product…

Product: Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 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
Quantity: 55 units (41 US, 14 OUS)
Codes and lots: Model/Catalog Number: S2190; UDI-DI: 05060494130510; Serial Numbers: 4006, 4007, 4008, 4011, 4018, 4023, 4025, 4027, 4031, 4032, 4034, 4039, 4041, 4051, 4052, 4053, 4056, 4057, 4061, 4069, 4075, 4092, 4093, 4098, 4102, 4115, 4119, 4129, 4131, 4135, 4145, 4146, 4147, 4149, 4150, 4154, 4155, 4156, 4160, 4161, 4162, 4014, 4040, 4045, 4060, 4063, 4064, 4067, 4089, 4104, 4108, 4118, 4128, 4136, 4142;
Recall started: July 24, 2025
Device type: Lamp, Infrared, Therapeutic Heating
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2417-2025

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A…

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
Quantity: 1 unit
Codes and lots: Model/Catalog Number: S2189; UDI-DI: 05060494130480; Only one device of this type is in scope. Serial number: 4068;
Recall started: July 24, 2025
Device type: Lamp, Infrared, Therapeutic Heating
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2418-2025

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A…

Product: Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 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
Quantity: 2 units (1 US, 1 OUS)
Codes and lots: Model/Catalog Number: S2186; UDI-DI: Serial numbers: 4005, 4062;
Recall started: July 24, 2025
Device type: Lamp, Infrared, Therapeutic Heating
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2419-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2416-2025, Z-2417-2025, Z-2418-2025, Z-2419-2025. The agency record governs; check it and the company before acting.

Report a mistake on this page