FDAFDA · Alimentos y medicamentos·N.º oficial Z-2419-2025
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
Publicado el 3 de septiembre de 2025 · Inicio del retiro: 24 de julio de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- THOR Photomedicine Ltd
- Distribuidor
- 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.
- Lote
- Model/Catalog Number: S2186; UDI-DI: Serial numbers: 4005, 4062;
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United Kingdom
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