Therapy Device Recall: THOR NovoTHOR S2188
Announced 2025-09-03 · FDA
The recall involves NovoTHOR therapy devices (model S2188) from THOR Photomedicine Ltd due to a potential welded nut failure that could detach the gas strut from the canopy, making the canopy difficult to lift. The recall covers about 80 units worldwide, including 66 in the United States and 14 outside the US. The issue is categorized with moderate severity.
| Brand | THOR Photomedicine Ltd |
|---|---|
| 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 |
| 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. |
| Severity | moderate |
| Units affected | 2 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | 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; |
WHAT YOU SHOULD DO
- Stop using the affected device and unplug it.
- Contact THOR Photomedicine Ltd for recall instructions and to verify if your unit is affected (check model S2188 and serial numbers).
- Do not attempt to repair the device yourself; follow instructions from THOR or FDA for repair, replacement, or return.
- Monitor official updates from THOR and the FDA and report any problems to your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.