Z-2417-2025 Class II Ongoing
FDA device recall Z-2417-2025 was initiated by THOR Photomedicine Ltd on July 24, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 55 units (41 US, 14 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units (41 US, 14 OUS)
Product Description
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
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.
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.
Code Information
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;