Food, drugs, devices › THOR Photomedicine Ltd
Device recall: Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoT
FDA enforcement event 97297 is a device recall by THOR Photomedicine Ltd of Amersham, initiated 24 Jul 2025 and classified Class II, with 4 product records.
FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. THOR Photomedicine Ltd has 3 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
THOR Photomedicine Ltd, Amersham, United Kingdom.
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
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2416-2025 | 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… | 80 units (66 US, 14 OUS) | Class II | Ongoing | 3 Sep 2025 |
| Z-2417-2025 | 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… | 55 units (41 US, 14 OUS) | Class II | Ongoing | 3 Sep 2025 |
| Z-2418-2025 | 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… | 1 unit | Class II | Ongoing | 3 Sep 2025 |
| 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… | 2 units (1 US, 1 OUS) | Class II | Ongoing | 3 Sep 2025 |
Context
Other enforcement events for THOR Photomedicine Ltd
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Nov 2023 | NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2 | Device | Class II | 1 |
| 13 Sep 2022 | NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 | Device | Class II | 4 |
All 3 events for THOR Photomedicine Ltd
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.